scholarly journals Executive Summary: Workshop on Issues in the Design and Conduct of Clinical Trials of Antibacterial Drugs in the Treatment of Community‐Acquired Pneumonia

2008 ◽  
Vol 47 (S3) ◽  
pp. S105-S107 ◽  
Author(s):  
Brad Spellberg ◽  
Thomas R. Fleming ◽  
David N. Gilbert
Keyword(s):  
Clinical Trials ◽  
Community Acquired Pneumonia ◽  
Executive Summary ◽  
Antibacterial Drugs

Mortality From Tuberculous Meningitis Reduced by Steroid Therapy

PEDIATRICS ◽  
1975 ◽  
Vol 56 (6) ◽  
pp. 1050-1055
Author(s):  
Jorge A. Escobar ◽  
Mark A. Belsey ◽  
Alvaro Dueñas ◽  
Pablo Medina
Keyword(s):  
Clinical Trials ◽  
Statistical Method ◽  
Steroid Therapy ◽  
Tuberculous Meningitis ◽  
Sequential Analysis ◽  
Matched Pairs ◽  
Antibacterial Drugs ◽  
Antituberculous Drugs

In this study of 99 tuberculous meningitis patients from Cali, Colombia, treatment with steroids (in conjunction with antituberculous drugs) was shown to be more effective in reducing mortality than treatment with antibacterial drugs alone. Results further suggest that low dosages of steroids (1 mg/kg of prednisone daily for 30 days) are equally effective in treating the disease as high dosages (10 mg/kg of prednisone at the start of treatment, gradually reduced over a 30-day period). These results are based on sequential analysis of matched pairs, a statistical method particularly appropriate for clinical trials.

scholarly journals Historical and Regulatory Perspectives on the Treatment Effect of Antibacterial Drugs for Community‐Acquired Pneumonia

2008 ◽  
Vol 47 (S3) ◽  
pp. S216-S224 ◽  
Author(s):  
M. Singer ◽  
S. Nambiar ◽  
T. Valappil ◽  
K. Higgins ◽  
S. Gitterman
Keyword(s):  
Treatment Effect ◽  
Community Acquired Pneumonia ◽  
Antibacterial Drugs

NHLBI clinical trials workshop: an executive summary

2012 ◽  
Vol 31 (25) ◽  
pp. 2938-2943 ◽  
Author(s):  
Gang Zheng ◽  
Colin O. Wu ◽  
Song Yang ◽  
Myron A. Waclawiw ◽  
David L. DeMets ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Executive Summary

scholarly journals Why participation in an international clinical trial platform matters during a pandemic? Launching REMAP-CAP in Japan

2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Kazuhiro Kamata ◽  
Kazuaki Jindai ◽  
Nao Ichihara ◽  
Hiroki Saito ◽  
Hideaki Kato ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Healthcare Workers ◽  
Emerging Infectious Diseases ◽  
Community Acquired Pneumonia ◽  
Global Network ◽  
Front Line ◽  
Multiple Stakeholders ◽  
Governmental Agencies ◽  
International Clinical Trial

AbstractREMAP-CAP, a randomized, embedded, multifactorial adaptive platform trial for community-acquired pneumonia, is an international clinical trial that is rapidly expanding its scope and scale in response to the COVID-19 pandemic. Japan is now joining REMAP-CAP with endorsement from Japanese academic societies. Commitment to REMAP-CAP can significantly contribute to population health through timely identification of optimal COVID-19 therapeutics. Additionally, it will promote the establishment of a national and global network of clinical trials to tackle future pandemics of emerging and re-emerging infectious diseases, in collaboration with multiple stakeholders, including front-line healthcare workers, governmental agencies, regulatory authorities, and academic societies.

scholarly journals PCV13 Vaccination of Adults against Pneumococcal Disease: What We Have Learned from the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA)

2022 ◽  
Vol 10 (1) ◽  
pp. 127
Author(s):  
Christian Theilacker ◽  
Mark A. Fletcher ◽  
Luis Jodar ◽  
Bradford D. Gessner
Keyword(s):  
Public Health ◽  
Clinical Trials ◽  
Older Adult ◽  
Pneumococcal Disease ◽  
Pneumococcal Vaccination ◽  
Community Acquired Pneumonia ◽  
The Public ◽  
Health Value ◽  
Health Relevance ◽  
Full Body

The Community-Acquired Pneumonia immunization Trial in Adults (CAPiTA) evaluated older adult pneumococcal vaccination and was one of the largest vaccine clinical trials ever conducted. Among older adults aged ≥65 years, the trial established 13-valent pneumococcal conjugate vaccine (PCV13) efficacy in preventing first episodes of bacteremic and nonbacteremic pneumococcal vaccine serotype (VT) community acquired pneumonia (CAP), and of vaccine serotype invasive pneumococcal disease (VT-IPD). Since the publication of the original trial results, 15 additional publications have extended the analyses. In this review, we summarize and integrate the full body of evidence generated by these studies, contextualize the results in light of their public health relevance, and discuss their implications for the assessment of current and future adult pneumococcal vaccination. This accumulating evidence has helped to better understand PCV13 efficacy, serotype-specific efficacy, efficacy in subgroups, the interpretation of immunogenicity data, and the public health value of adult PCV vaccination.

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