Deferred Consent in Neonatal Clinical Research: Why, When, How?
We present a framework based on neonatal deferred consent trials that assess both non-drug and drug interventions, our experience conducting deferred consent neonatal studies in Australia, and the views of providers and parents on how to best implement deferred consent in the neonatal research setting.PMID:34651279 | DOI:10.1007/s40272-021-00473-z (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 15, 2021 Category: Pediatrics Authors: Dilini I Imbulana Louise S Owen Trisha M Prentice Peter G Davis Brett J Manley Source Type: research

Deferred Consent in Neonatal Clinical Research: Why, When, How?
We present a framework based on neonatal deferred consent trials that assess both non-drug and drug interventions, our experience conducting deferred consent neonatal studies in Australia, and the views of providers and parents on how to best implement deferred consent in the neonatal research setting.PMID:34651279 | DOI:10.1007/s40272-021-00473-z (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 15, 2021 Category: Pediatrics Authors: Dilini I Imbulana Louise S Owen Trisha M Prentice Peter G Davis Brett J Manley Source Type: research

Deferred Consent in Neonatal Clinical Research: Why, When, How?
We present a framework based on neonatal deferred consent trials that assess both non-drug and drug interventions, our experience conducting deferred consent neonatal studies in Australia, and the views of providers and parents on how to best implement deferred consent in the neonatal research setting.PMID:34651279 | DOI:10.1007/s40272-021-00473-z (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 15, 2021 Category: Pediatrics Authors: Dilini I Imbulana Louise S Owen Trisha M Prentice Peter G Davis Brett J Manley Source Type: research

Use of Furosemide and Chlorothiazide Combination Continuous Infusion in Furosemide-Refractory Patients in the Pediatric Intensive Care Unit: A Retrospective Cohort Study
Paediatr Drugs. 2021 Oct 11. doi: 10.1007/s40272-021-00472-0. Online ahead of print.ABSTRACTOBJECTIVE: Our objective was to describe the efficacy and safety of furosemide and chlorothiazide combination continuous infusion (FCCCI) in children in a pediatric intensive care unit (ICU), including postoperative cardiac patients.METHODS: This was a retrospective cohort study in a pediatric ICU within a tertiary care teaching hospital. Children aged
Source: Paediatric Drugs - October 11, 2021 Category: Pediatrics Authors: Summer R Record Aaron A Harthan Sandeep Tripathi Source Type: research

Use of Furosemide and Chlorothiazide Combination Continuous Infusion in Furosemide-Refractory Patients in the Pediatric Intensive Care Unit: A Retrospective Cohort Study
Paediatr Drugs. 2021 Oct 11. doi: 10.1007/s40272-021-00472-0. Online ahead of print.ABSTRACTOBJECTIVE: Our objective was to describe the efficacy and safety of furosemide and chlorothiazide combination continuous infusion (FCCCI) in children in a pediatric intensive care unit (ICU), including postoperative cardiac patients.METHODS: This was a retrospective cohort study in a pediatric ICU within a tertiary care teaching hospital. Children aged
Source: Paediatric Drugs - October 11, 2021 Category: Pediatrics Authors: Summer R Record Aaron A Harthan Sandeep Tripathi Source Type: research

Use of Furosemide and Chlorothiazide Combination Continuous Infusion in Furosemide-Refractory Patients in the Pediatric Intensive Care Unit: A Retrospective Cohort Study
Paediatr Drugs. 2021 Oct 11. doi: 10.1007/s40272-021-00472-0. Online ahead of print.ABSTRACTOBJECTIVE: Our objective was to describe the efficacy and safety of furosemide and chlorothiazide combination continuous infusion (FCCCI) in children in a pediatric intensive care unit (ICU), including postoperative cardiac patients.METHODS: This was a retrospective cohort study in a pediatric ICU within a tertiary care teaching hospital. Children aged
Source: Paediatric Drugs - October 11, 2021 Category: Pediatrics Authors: Summer R Record Aaron A Harthan Sandeep Tripathi Source Type: research

Use of Furosemide and Chlorothiazide Combination Continuous Infusion in Furosemide-Refractory Patients in the Pediatric Intensive Care Unit: A Retrospective Cohort Study
Paediatr Drugs. 2021 Oct 11. doi: 10.1007/s40272-021-00472-0. Online ahead of print.ABSTRACTOBJECTIVE: Our objective was to describe the efficacy and safety of furosemide and chlorothiazide combination continuous infusion (FCCCI) in children in a pediatric intensive care unit (ICU), including postoperative cardiac patients.METHODS: This was a retrospective cohort study in a pediatric ICU within a tertiary care teaching hospital. Children aged
Source: Paediatric Drugs - October 11, 2021 Category: Pediatrics Authors: Summer R Record Aaron A Harthan Sandeep Tripathi Source Type: research

Correction to: Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Oct 7. doi: 10.1007/s40272-021-00474-y. Online ahead of print.NO ABSTRACTPMID:34617260 | DOI:10.1007/s40272-021-00474-y (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 7, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Correction to: Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Oct 7. doi: 10.1007/s40272-021-00474-y. Online ahead of print.NO ABSTRACTPMID:34617260 | DOI:10.1007/s40272-021-00474-y (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 7, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Correction to: Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Oct 7. doi: 10.1007/s40272-021-00474-y. Online ahead of print.NO ABSTRACTPMID:34617260 | DOI:10.1007/s40272-021-00474-y (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 7, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Correction to: Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Oct 7. doi: 10.1007/s40272-021-00474-y. Online ahead of print.NO ABSTRACTPMID:34617260 | DOI:10.1007/s40272-021-00474-y (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 7, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Teriflunomide: Pediatric First Approval
This article summarizes the milestones in the development of teriflunomide leading to this first pediatric approval for relapsing-remitting MS.PMID:34595696 | DOI:10.1007/s40272-021-00471-1 (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 1, 2021 Category: Pediatrics Authors: Julia Paik Source Type: research

Teriflunomide: Pediatric First Approval
This article summarizes the milestones in the development of teriflunomide leading to this first pediatric approval for relapsing-remitting MS.PMID:34595696 | DOI:10.1007/s40272-021-00471-1 (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 1, 2021 Category: Pediatrics Authors: Julia Paik Source Type: research

Teriflunomide: Pediatric First Approval
This article summarizes the milestones in the development of teriflunomide leading to this first pediatric approval for relapsing-remitting MS.PMID:34595696 | DOI:10.1007/s40272-021-00471-1 (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 1, 2021 Category: Pediatrics Authors: Julia Paik Source Type: research

Teriflunomide: Pediatric First Approval
This article summarizes the milestones in the development of teriflunomide leading to this first pediatric approval for relapsing-remitting MS.PMID:34595696 | DOI:10.1007/s40272-021-00471-1 (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 1, 2021 Category: Pediatrics Authors: Julia Paik Source Type: research

Teriflunomide: Pediatric First Approval
This article summarizes the milestones in the development of teriflunomide leading to this first pediatric approval for relapsing-remitting MS.PMID:34595696 | DOI:10.1007/s40272-021-00471-1 (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 1, 2021 Category: Pediatrics Authors: Julia Paik Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Managing Adverse Events Associated with Dinutuximab Beta Treatment in Patients with High-Risk Neuroblastoma: Practical Guidance
Paediatr Drugs. 2021 Sep 20. doi: 10.1007/s40272-021-00469-9. Online ahead of print.ABSTRACTNeuroblastoma is the most common extracranial solid tumour in children, accounting for 15% of all paediatric cancer deaths. High-risk neuroblastoma is a particularly challenging-to-treat form of disease that requires multimodality treatment, consisting of chemotherapy, surgery, high-dose chemotherapy with autologous haematopoietic stem cell rescue, radiotherapy and differentiation therapy. However, despite intense multimodal treatment regimens, the prognosis for this patient population remains poor. In recent years, immunotherapy wi...
Source: Paediatric Drugs - September 20, 2021 Category: Pediatrics Authors: Giuseppe Barone Ailish Barry Francisco Bautista B énédicte Brichard Anne-Sophie Defachelles Fiona Herd Carla Manzitti Dirk Reinhardt Pedro M Rubio Aleksandra Wieczorek Max M van Noesel Source Type: research

Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials
Paediatr Drugs. 2021 Sep 15. doi: 10.1007/s40272-021-00470-2. Online ahead of print.ABSTRACTAIM: The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6-17 years of age) with attention-deficit/hyperactivity disorder (ADHD).METHODS: Data from four phase III placebo-controlled trials of 100-600 mg/day viloxazine ER (6-8 weeks of treatment) were used to evaluate the change from baseline (CFB) in the Conners 3rd Edition Parent Short Form-Executive Function (C3PS-EF) content scale T-score. Subjects wer...
Source: Paediatric Drugs - September 15, 2021 Category: Pediatrics Authors: Stephen V Faraone Roberto Gomeni Joseph T Hull Gregory D Busse Zare Melyan Jonathan Rubin Azmi Nasser Source Type: research

Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials
Paediatr Drugs. 2021 Sep 15. doi: 10.1007/s40272-021-00470-2. Online ahead of print.ABSTRACTAIM: The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6-17 years of age) with attention-deficit/hyperactivity disorder (ADHD).METHODS: Data from four phase III placebo-controlled trials of 100-600 mg/day viloxazine ER (6-8 weeks of treatment) were used to evaluate the change from baseline (CFB) in the Conners 3rd Edition Parent Short Form-Executive Function (C3PS-EF) content scale T-score. Subjects wer...
Source: Paediatric Drugs - September 15, 2021 Category: Pediatrics Authors: Stephen V Faraone Roberto Gomeni Joseph T Hull Gregory D Busse Zare Melyan Jonathan Rubin Azmi Nasser Source Type: research

Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials
Paediatr Drugs. 2021 Sep 15. doi: 10.1007/s40272-021-00470-2. Online ahead of print.ABSTRACTAIM: The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6-17 years of age) with attention-deficit/hyperactivity disorder (ADHD).METHODS: Data from four phase III placebo-controlled trials of 100-600 mg/day viloxazine ER (6-8 weeks of treatment) were used to evaluate the change from baseline (CFB) in the Conners 3rd Edition Parent Short Form-Executive Function (C3PS-EF) content scale T-score. Subjects wer...
Source: Paediatric Drugs - September 15, 2021 Category: Pediatrics Authors: Stephen V Faraone Roberto Gomeni Joseph T Hull Gregory D Busse Zare Melyan Jonathan Rubin Azmi Nasser Source Type: research

Executive Function Outcome of Treatment with Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Post-Hoc Analysis of Four Randomized Clinical Trials
Paediatr Drugs. 2021 Sep 15. doi: 10.1007/s40272-021-00470-2. Online ahead of print.ABSTRACTAIM: The aim of this study was to evaluate the effect of viloxazine extended-release capsules (viloxazine ER; Qelbree™) on executive function deficits (EFDs) in pediatric subjects (6-17 years of age) with attention-deficit/hyperactivity disorder (ADHD).METHODS: Data from four phase III placebo-controlled trials of 100-600 mg/day viloxazine ER (6-8 weeks of treatment) were used to evaluate the change from baseline (CFB) in the Conners 3rd Edition Parent Short Form-Executive Function (C3PS-EF) content scale T-score. Subjects wer...
Source: Paediatric Drugs - September 15, 2021 Category: Pediatrics Authors: Stephen V Faraone Roberto Gomeni Joseph T Hull Gregory D Busse Zare Melyan Jonathan Rubin Azmi Nasser Source Type: research

Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Aug 31. doi: 10.1007/s40272-021-00468-w. Online ahead of print.ABSTRACTCommunity-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vit...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial
CONCLUSION: There were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6-11 years treated with dupilumab + TCS for severe AD.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03345914. Does treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with severe atopic de...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Amy S Paller Andreas Wollenberg Elaine Siegfried Diamant Tha çi Michael J Cork Peter D Arkwright Melinda Gooderham Xian Sun John T O'Malley Faisal A Khokhar Jignesh Vakil Ashish Bansal Karli Rosner Brad Shumel Noah A Levit Source Type: research

Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Aug 31. doi: 10.1007/s40272-021-00468-w. Online ahead of print.ABSTRACTCommunity-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vit...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial
CONCLUSION: There were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6-11 years treated with dupilumab + TCS for severe AD.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03345914. Does treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with severe atopic de...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Amy S Paller Andreas Wollenberg Elaine Siegfried Diamant Tha çi Michael J Cork Peter D Arkwright Melinda Gooderham Xian Sun John T O'Malley Faisal A Khokhar Jignesh Vakil Ashish Bansal Karli Rosner Brad Shumel Noah A Levit Source Type: research

Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Aug 31. doi: 10.1007/s40272-021-00468-w. Online ahead of print.ABSTRACTCommunity-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vit...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial
CONCLUSION: There were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6-11 years treated with dupilumab + TCS for severe AD.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03345914. Does treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with severe atopic de...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Amy S Paller Andreas Wollenberg Elaine Siegfried Diamant Tha çi Michael J Cork Peter D Arkwright Melinda Gooderham Xian Sun John T O'Malley Faisal A Khokhar Jignesh Vakil Ashish Bansal Karli Rosner Brad Shumel Noah A Levit Source Type: research

Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Aug 31. doi: 10.1007/s40272-021-00468-w. Online ahead of print.ABSTRACTCommunity-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vit...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial
CONCLUSION: There were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6-11 years treated with dupilumab + TCS for severe AD.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03345914. Does treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with severe atopic de...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Amy S Paller Andreas Wollenberg Elaine Siegfried Diamant Tha çi Michael J Cork Peter D Arkwright Melinda Gooderham Xian Sun John T O'Malley Faisal A Khokhar Jignesh Vakil Ashish Bansal Karli Rosner Brad Shumel Noah A Levit Source Type: research

Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Aug 31. doi: 10.1007/s40272-021-00468-w. Online ahead of print.ABSTRACTCommunity-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vit...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial
CONCLUSION: There were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6-11 years treated with dupilumab + TCS for severe AD.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03345914. Does treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with severe atopic de...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Amy S Paller Andreas Wollenberg Elaine Siegfried Diamant Tha çi Michael J Cork Peter D Arkwright Melinda Gooderham Xian Sun John T O'Malley Faisal A Khokhar Jignesh Vakil Ashish Bansal Karli Rosner Brad Shumel Noah A Levit Source Type: research

Ceftaroline Fosamil for Treatment of Pediatric Complicated Skin and Soft Tissue Infections and Community-Acquired Pneumonia
Paediatr Drugs. 2021 Aug 31. doi: 10.1007/s40272-021-00468-w. Online ahead of print.ABSTRACTCommunity-acquired pneumonia (CAP)/community-acquired bacterial pneumonia (CABP) and complicated skin and soft tissue infection (cSSTI)/acute bacterial skin and skin structure infection (ABSSSI) represent major causes of morbidity and mortality in children. β-Lactams are the cornerstone of antibiotic treatment for many serious bacterial infections in children; however, most of these agents have no activity against methicillin-resistant Staphylococcus aureus (MRSA). Ceftaroline fosamil, a β-lactam with broad-spectrum in vit...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Susanna Esposito Timothy J Carrothers Todd Riccobene Gregory G Stone Michal Kantecki Source Type: research

Laboratory Safety of Dupilumab in Patients Aged 6-11 Years with Severe Atopic Dermatitis: Results from a Phase III Clinical Trial
CONCLUSION: There were no clinically meaningful adverse changes in routine laboratory parameters attributable to treatment with dupilumab + TCS. Changes in platelet counts and lactate dehydrogenase levels likely reflect reduced inflammation. These results confirm similar findings in adults and adolescents, and suggest that there is no need for routine laboratory monitoring of children aged 6-11 years treated with dupilumab + TCS for severe AD.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03345914. Does treatment with dupilumab require routine laboratory monitoring in 6- to 11-year-old children with severe atopic de...
Source: Paediatric Drugs - August 31, 2021 Category: Pediatrics Authors: Amy S Paller Andreas Wollenberg Elaine Siegfried Diamant Tha çi Michael J Cork Peter D Arkwright Melinda Gooderham Xian Sun John T O'Malley Faisal A Khokhar Jignesh Vakil Ashish Bansal Karli Rosner Brad Shumel Noah A Levit Source Type: research

Potential Antibiotics for the Treatment of Neonatal Sepsis Caused by Multidrug-Resistant Bacteria
We describe the available characteristics of each in terms of mechanism of action, resistance mechanisms, clinical pharmacokinetics, pharmacodynamics, and toxicity profile. We also identify some knowledge gaps: (1) the neonatal pharmacokinetics of cefepime is reliant on relatively small and limited datasets, and the pharmacokinetics of flomoxef are also reliant on data from a limited demographic range and (2) for all reviewed agents, the pharmacodynamic index and target has not been definitively established for both bactericidal effect and emergence of resistance, with many assumed to have an identical index/target to simi...
Source: Paediatric Drugs - August 26, 2021 Category: Pediatrics Authors: Christopher A Darlow Renata M A da Costa Sally Ellis Fran çois Franceschi Mike Sharland Laura Piddock Shampa Das William Hope Source Type: research

Potential Antibiotics for the Treatment of Neonatal Sepsis Caused by Multidrug-Resistant Bacteria
We describe the available characteristics of each in terms of mechanism of action, resistance mechanisms, clinical pharmacokinetics, pharmacodynamics, and toxicity profile. We also identify some knowledge gaps: (1) the neonatal pharmacokinetics of cefepime is reliant on relatively small and limited datasets, and the pharmacokinetics of flomoxef are also reliant on data from a limited demographic range and (2) for all reviewed agents, the pharmacodynamic index and target has not been definitively established for both bactericidal effect and emergence of resistance, with many assumed to have an identical index/target to simi...
Source: Paediatric Drugs - August 26, 2021 Category: Pediatrics Authors: Christopher A Darlow Renata M A da Costa Sally Ellis Fran çois Franceschi Mike Sharland Laura Piddock Shampa Das William Hope Source Type: research

Potential Antibiotics for the Treatment of Neonatal Sepsis Caused by Multidrug-Resistant Bacteria
We describe the available characteristics of each in terms of mechanism of action, resistance mechanisms, clinical pharmacokinetics, pharmacodynamics, and toxicity profile. We also identify some knowledge gaps: (1) the neonatal pharmacokinetics of cefepime is reliant on relatively small and limited datasets, and the pharmacokinetics of flomoxef are also reliant on data from a limited demographic range and (2) for all reviewed agents, the pharmacodynamic index and target has not been definitively established for both bactericidal effect and emergence of resistance, with many assumed to have an identical index/target to simi...
Source: Paediatric Drugs - August 26, 2021 Category: Pediatrics Authors: Christopher A Darlow Renata M A da Costa Sally Ellis Fran çois Franceschi Mike Sharland Laura Piddock Shampa Das William Hope Source Type: research

Potential Antibiotics for the Treatment of Neonatal Sepsis Caused by Multidrug-Resistant Bacteria
We describe the available characteristics of each in terms of mechanism of action, resistance mechanisms, clinical pharmacokinetics, pharmacodynamics, and toxicity profile. We also identify some knowledge gaps: (1) the neonatal pharmacokinetics of cefepime is reliant on relatively small and limited datasets, and the pharmacokinetics of flomoxef are also reliant on data from a limited demographic range and (2) for all reviewed agents, the pharmacodynamic index and target has not been definitively established for both bactericidal effect and emergence of resistance, with many assumed to have an identical index/target to simi...
Source: Paediatric Drugs - August 26, 2021 Category: Pediatrics Authors: Christopher A Darlow Renata M A da Costa Sally Ellis Fran çois Franceschi Mike Sharland Laura Piddock Shampa Das William Hope Source Type: research

Targeted Therapy in Pediatric AML: An Evolving Landscape
Paediatr Drugs. 2021 Aug 22. doi: 10.1007/s40272-021-00467-x. Online ahead of print.ABSTRACTThe outcomes associated with pediatric acute myeloid leukemia (AML) have improved over the last few decades, with the implementation of intensive chemotherapy, hematopoietic stem cell transplant, and improved supportive care. However, even with intensive therapy and the use of HSCT, both of which carry significant risks of short- and long-term side effects, approximately 30% of children are not able to be cured. The characterization of AML in pediatrics has evolved over time and it currently involves use of a variety of diagnostic t...
Source: Paediatric Drugs - August 22, 2021 Category: Pediatrics Authors: LaQuita M Jones Katherine Tarlock Todd Cooper Source Type: research

Targeted Therapy in Pediatric AML: An Evolving Landscape
Paediatr Drugs. 2021 Aug 22. doi: 10.1007/s40272-021-00467-x. Online ahead of print.ABSTRACTThe outcomes associated with pediatric acute myeloid leukemia (AML) have improved over the last few decades, with the implementation of intensive chemotherapy, hematopoietic stem cell transplant, and improved supportive care. However, even with intensive therapy and the use of HSCT, both of which carry significant risks of short- and long-term side effects, approximately 30% of children are not able to be cured. The characterization of AML in pediatrics has evolved over time and it currently involves use of a variety of diagnostic t...
Source: Paediatric Drugs - August 22, 2021 Category: Pediatrics Authors: LaQuita M Jones Katherine Tarlock Todd Cooper Source Type: research

Targeted Therapy in Pediatric AML: An Evolving Landscape
Paediatr Drugs. 2021 Aug 22. doi: 10.1007/s40272-021-00467-x. Online ahead of print.ABSTRACTThe outcomes associated with pediatric acute myeloid leukemia (AML) have improved over the last few decades, with the implementation of intensive chemotherapy, hematopoietic stem cell transplant, and improved supportive care. However, even with intensive therapy and the use of HSCT, both of which carry significant risks of short- and long-term side effects, approximately 30% of children are not able to be cured. The characterization of AML in pediatrics has evolved over time and it currently involves use of a variety of diagnostic t...
Source: Paediatric Drugs - August 22, 2021 Category: Pediatrics Authors: LaQuita M Jones Katherine Tarlock Todd Cooper Source Type: research

Targeted Therapy in Pediatric AML: An Evolving Landscape
Paediatr Drugs. 2021 Aug 22. doi: 10.1007/s40272-021-00467-x. Online ahead of print.ABSTRACTThe outcomes associated with pediatric acute myeloid leukemia (AML) have improved over the last few decades, with the implementation of intensive chemotherapy, hematopoietic stem cell transplant, and improved supportive care. However, even with intensive therapy and the use of HSCT, both of which carry significant risks of short- and long-term side effects, approximately 30% of children are not able to be cured. The characterization of AML in pediatrics has evolved over time and it currently involves use of a variety of diagnostic t...
Source: Paediatric Drugs - August 22, 2021 Category: Pediatrics Authors: LaQuita M Jones Katherine Tarlock Todd Cooper Source Type: research

Managing Patient Pressure to Prescribe Antibiotics in the Clinic
Paediatr Drugs. 2021 Aug 19:1-7. doi: 10.1007/s40272-021-00466-y. Online ahead of print.ABSTRACTAcute respiratory tract infections (ARTIs) are typically viral; however, in the USA, approximately one-third of adults and 52% of children with ARTIs receive an antibiotic, making antibiotic prescribing for ARTIs a major contributor to the problem of inappropriate prescribing. Relying on a synthesis of work across pediatric and adult primary care, this article shows some of the main ways that patients and parents pressure physicians for antibiotics, whether intentionally or unintentionally, and how physicians combat that pressur...
Source: Paediatric Drugs - August 19, 2021 Category: Pediatrics Authors: Tanya Stivers Source Type: research