Experiences and challenges with the new European Clinical Trials Regulation
ConclusionsCTIS promised to lower the administrative bar, but unfortunately this has not been achieved. There are challenges that need to be urgently confronted and addressed for international research collaborators to effectively manage health crises in the future. While the value of multi-national outbreak research is clear, the limitations and delays imposed by the system, which raise challenging ethical questions about the regulation, are prejudicial to all clinical research, especially publicly funded academic studies. This report is relevant to both regulators and clinical researchers. It is hoped that these findings...
Source: Trials - January 2, 2024 Category: Research Source Type: clinical trials

A Phase 1b Clinical Trial of 13-valent Pneumococcal Polysaccharide Conjugate Vaccine
Conditions: Pneumococcal Infectious Disease Interventions: Biological: Sinovac PCV13; Biological: PREVNAR 13 Sponsors: Sinovac Research and Development Co., Ltd. Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 27, 2023 Category: Research Source Type: clinical trials

Pneumonia Direct Pilot
Conditions: Pneumonia, Bacterial; Ventilator Associated Pneumonia Interventions: Diagnostic Test: Pathogen and Host Directed testing Sponsors: Duke University; National Institute of Allergy and Infectious Diseases (NIAID) Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 25, 2023 Category: Research Source Type: clinical trials

Bubonic plague: can the size of buboes be accurately and consistently measured with a digital calliper?
ConclusionsThe results of this study demonstrate the challenges for both individual and multiple raters to repeatedly generate consistent and accurate measurements of the same artificial buboes with a digital calliper. (Source: Trials)
Source: Trials - December 19, 2023 Category: Research Source Type: clinical trials

Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
Conditions: Gram-negative Bacteremia; Bloodstream Infection Interventions: Diagnostic Test: Reveal Sponsors: Duke University; National Institute of Allergy and Infectious Diseases (NIAID); Parexel; BioM érieux Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 18, 2023 Category: Research Source Type: clinical trials

Contribution of a Video Support to Inform the Patient Before a Complementary Examination in Infectious Diseases
Conditions: Infectious Disease Interventions: Other: Oral and written information; Other: Video information Sponsors: Assistance Publique - H ôpitaux de Paris Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 13, 2023 Category: Research Source Type: clinical trials

Detection and Characterization of Neurologic Manifestations of Inborn and Acquired Errors of Immunity
Conditions: Nervous System Disease; Immune System Disease Sponsors: National Institute of Allergy and Infectious Diseases (NIAID) Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 13, 2023 Category: Research Source Type: clinical trials

Association of Dysbiosis and Immune Response in Bronchiolitis in Under 12 Months -Old Infants
Conditions: Newborns With Bronchiolitis Interventions: Other: Sampling Sponsors: Assistance Publique - H ôpitaux de Paris; Infectious Diseases Models for Innovative Therapies center Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 7, 2023 Category: Research Source Type: clinical trials

D-SOLVE Cohorts (Cohort A and B)
Conditions: HDV; HDV Infection; Chronic Liver Disease Sponsors: Hannover Medical School; Karolinska University Hospital; Karolinska Institutet; Helmholtz Centre for Infection Research; Fondazione IRCCS Ca ' Granda, Ospedale Maggiore Policlinico; National Institute of Infectious Diseases Matei Bals Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 7, 2023 Category: Research Source Type: clinical trials

Infectious Prospective Collection for Biological Analysis
Conditions: Infectious Disease Interventions: Other: Blood sample Sponsors: CerbaXpert Recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 6, 2023 Category: Research Source Type: clinical trials

A blueprint for a multi-disease, multi-domain Bayesian adaptive platform trial incorporating adult and paediatric subgroups: the Staphylococcus aureus Network Adaptive Platform trial
AbstractTheStaphylococcus aureus Network Adaptive Platform (SNAP) trial is a multifactorial Bayesian adaptive platform trial that aims to improve the way thatS. aureus bloodstream infection, a globally common and severe infectious disease, is treated. In a world first, the SNAP trial will simultaneously investigate the effects of multiple intervention modalities within multiple groups of participants with different forms ofS. aureus bloodstream infection. Here, we formalise the trial structure, modelling approach, and decision rules that will be used for the SNAP trial. By summarising the statistical principles governing t...
Source: Trials - December 6, 2023 Category: Research Source Type: clinical trials

European Trial Into Mpox Infection
Conditions: Monkeypox Interventions: Drug: Tecovirimat Oral Capsule; Drug: Placebo Sponsors: Miquel Ekkelenkamp; European Clinical Research Alliance for Infectious Diseases (ECRAID); Universiteit Antwerpen; Erasmus Medical Center Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 5, 2023 Category: Research Source Type: clinical trials

PROmotion of COVID-19 BOOSTer VA(X)Ccination in the Emergency Department - PROBOOSTVAXED
Conditions: COVID-19 Interventions: Behavioral: Vaccine Messaging; Behavioral: Vaccine Acceptance Question Sponsors: University of California, San Francisco; National Institute of Allergy and Infectious Diseases (NIAID); Pfizer; Duke University; Baylor College of Medicine; Thomas Jefferson University Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 5, 2023 Category: Research Source Type: clinical trials

Investigation of Immune Amnesia Following Measles Infection in Select African Regions
Conditions: Measles Infection Interventions: Biological: Verorab Sponsors: National Institute of Allergy and Infectious Diseases (NIAID); Johns Hopkins University Not yet recruiting (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - December 1, 2023 Category: Research Source Type: clinical trials

Testing a Barbershop-based HIV Prevention Initiative Among Men
Conditions: HIV Infections Interventions: Behavioral: General, status-neutral HIV education; Diagnostic Test: HIV self-test kits; Other: Information about where to receive HIV prevention services; Behavioral: Barber-led peer support group education; Behavioral: Facility-based HIV risk reduction counseling; Diagnostic Test: Facility-based HIV testing; Other: Information about facility distributed HIV self-test kits; Diagnostic Test: STI testing Sponsors: HIV Prevention Trials Network; Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH); National Instit...
Source: ClinicalTrials.gov - November 28, 2023 Category: Research Source Type: clinical trials