DDT COA #000018: Pneumonia Patient-Reported Outcome Measure (PNEUMO-PRO) specific to CABP and HABP

Clinical Outcome Assessments (COA) Qualification Submissions Office of Antimicrobial Products (OAP) Division of Anti-Infective Products (DAIP) DDT COA Number DDT COA #000018
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news

Related Links:

ConclusionIn SLE cases, IP primarily occurred in male and elderly patients. In addition to the NSIP pattern, the UIP pattern was evident on HRCT scans of IP-related SLE. The survival of SLE patients was unrelated to IP.
Source: Respiratory Investigation - Category: Respiratory Medicine Source Type: research
Abstract The amoeba-resistant bacterium Legionella pneumophila infects humans through aerosols and thereby can cause a life-threatening pneumonia termed Legionnaires' disease. In the environment L. pneumophila forms and colonizes biofilms, which usually comprise complex multispecies communities. In these biofilms L. pneumophila persists and replicates intracellularly in protozoa, such as the amoeba Acanthamoeba castellanii. The interactions between sessile L. pneumophila in biofilms and their natural protozoan hosts are not understood on a molecular level. Here, we describe a method to visualize by confocal m...
Source: Mol Biol Cell - Category: Molecular Biology Authors: Tags: Methods Mol Biol Source Type: research
Publication date: Available online 21 June 2019Source: The Journal of Molecular DiagnosticsAuthor(s): Karissa Culbreath, Suzanne Melanson, James Gale, Justin Baker, Fan Li, Oystein Saebo, Oyvind Kommedal, Deisy Contreras, Omai B. Garner, Shangxin YangNext-generation sequencing–based 16S rRNA gene metagenomic sequencing (16S MG) technology has tremendous potential for improving diagnosis of bacterial infections given its quantitative capability and culture-independent approach. We validated and utilized a quantitative 16S MG assay to identify and quantify bacterial species in clinical samples from a wide spectrum of i...
Source: The Journal of Molecular Diagnostics - Category: Pathology Source Type: research
Publication date: Available online 20 June 2019Source: The LancetAuthor(s): Kewu Huang, Ting Yang, Jianying Xu, Lan Yang, Jianping Zhao, Xiangyan Zhang, Chunxue Bai, Jian Kang, Pixin Ran, Huahao Shen, Fuqiang Wen, Yahong Chen, Tieying Sun, Guangliang Shan, Yingxiang Lin, Guodong Xu, Sinan Wu, Chaolong Wang, Ruiying Wang, Zhihong ShiSummaryBackgroundAsthma is a common chronic airway disease worldwide. Despite its large population size, China has had no comprehensive study of the national prevalence, risk factors, and management of asthma. We therefore aimed to estimate the national prevalence of asthma in a representative s...
Source: The Lancet - Category: General Medicine Source Type: research
A 16-year-old healthy male presented to the emergency department with a 5-day history of upper respiratory symptoms, persistent fever, and blisters present within the oral cavity. Two days before presentation, he also developed severe bilateral conjunctivitis with watery discharge. There were no other symptoms such as respiratory distress, skin rash, and genital lesions. He was not sexually active and denied taking any medications recently. His vitals were within normal limits. However, he appeared to be in distress that was secondary to pain.
Source: Pediatrics and Neonatology - Category: Perinatology & Neonatology Authors: Tags: Letter to the Editor Source Type: research
Infection is a frequent medical complication after stroke1 with an observed pooled frequency from a recent meta-analysis of 21%, most frequently involving the lungs (12%) and urinary tract (8%).2 The mechanisms leading to post-stroke infections are complex and include a combination of brain injury-induced immunosuppression, neurological impairment that fosters lung aspiration, immobilization, and use of urinary catheters.3,4 Post-stroke infections, in general, are associated with lower survival and less favorable neurologic outcomes.
Source: Journal of Infection - Category: Infectious Diseases Authors: Source Type: research
We describe three cases of breakthrough pneumococcal severe life-threatening infections, including two meningitis and one bloodstream infection in patients treated with cefixime for otitis, sinusitis and pneumonia, respectively. Cefixime does not seem to be fully effective in treating invasive pneumococcal diseases. Because penicillin non-susceptibility might be linked to cefixime failure, the prompt knowledge of susceptibility to penicillin in S. pneumoniae might be very useful. Furthermore, MIC of cefixime should be measured because values>0.5 mg/L might be related to failure. PMID: 31215358 [PubMed - as supplied by publisher]
Source: Journal of Chemotherapy - Category: Cancer & Oncology Tags: J Chemother Source Type: research
Conclusions: The combination of ibrutinib 560 mg daily and durvalumab 10 mg/kg every 2 weeks had an acceptable safety profile. The antitumor activity of the ibrutinib-durvalumab combination was limited in our study population.Oncology
Source: Oncology - Category: Cancer & Oncology Source Type: research
Authors: Saleem Z, Godman B, Hassali MA, Hashmi FK, Azhar F, Rehman IU Abstract Health-care-associated infections (HAIs) are considered a serious public health issues that contribute substantially to the global burden of mortality and morbidity with respect to infectious diseases. The aim is to assess the burden of health-care-associated infections by collation of available data from published point prevalence surveys (PPS) on HAIs to give future guidance. Study protocol and methodology were designed according to preferred reporting items for systematic reviews and meta-analysis (PRISMA) guidelines. Published resea...
Source: Pathogens and Global Health - Category: International Medicine & Public Health Tags: Pathog Glob Health Source Type: research
Abstract To determine the association between daily air pollution and the hospital admissions for respiratory diseases in children aged from 0 to 17 years in Jinan, China. Generalized linear models were used to explore the acute effects of ambient fine particulate matter (PM2.5) on the children's hospital admissions for respiratory diseases. We evaluated the lag associations (including lag 0 to lag 3, lag 01, and lag 03) between daily PM2.5 and the number of children's hospital admissions for respiratory diseases, and stratified by gender, age group (baby group: age 0-1 years; child group: age 1-5 years; student g...
Source: Environmental Science and Pollution Research International - Category: Environmental Health Authors: Tags: Environ Sci Pollut Res Int Source Type: research
More News: Drugs & Pharmacology | Pneumonia