ArticleClinical investigation2011
Design of clinical trials of antibacterial agents for community-acquired bacterial pneumonia.
Article in Clinical investigation, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 14 citations in OpenAlex.
- Developing Consensus on Clinical Outcomes for Children with Mild Pneumonia: A Delphi Study.Journal of the Pediatric Infectious Diseases Society · 2023Article
- Discordance Among Antibiotic Prescription Guidelines Reflects a Lack of Clear Best Practices.Open forum infectious diseases · 2021Article
- A Retrospective Analysis of Probability of Target Attainment in Community-Acquired Pneumonia: Ceftaroline Fosamil Versus Comparators.Infectious diseases and therapy · 2019Article
- Novel approaches are needed to develop tomorrow's antibacterial therapies.American journal of respiratory and critical care medicine · 2015Review
- The future of antibiotics.Critical care (London, England) · 2014Review
- White paper: recommendations on the conduct of superiority and organism-specific clinical trials of antibacterial agents for the treatment of infections caused by drug-resistant bacterial pathogens.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2012Article
- Combating antimicrobial resistance: policy recommendations to save lives.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2011Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
Abstract
Standards for the conduct of clinical trials of antibacterial agents for community-acquired bacterial pneumonia (CABP) have changed dramatically in recent years. A draft guidance from the US FDA on the conduct of such trials was issued in March 2009. However, the guidance has already faced substantial criticism during the open public comment period, resulting in uncertainty regarding the appropriate design of such studies from a regulatory perspective. Controversies regarding the magnitude of the treatment effect associated with antibacterial therapy versus placebo/no therapy, the appropriate timing, nature and noninferiority margin for the primary efficacy end point, and other clinical and statistical issues have complicated efforts to reach consensus on appropriate trial design of antibacterial therapy for CABP. It is critical that studies of new drugs for CABP are designed to ensure that they are feasible to conduct and that their results are scientifically valid, statistically rigorous and clinically meaningful. Based on 3 years of active dialog between clinical, statistical, and regulatory experts, this article proposes an approach to enable a balance of clinical trial feasibility with appropriate scientific, statistical and clinical rigor.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.