ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012
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.
Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02709408 (Prospective Observational Study to Assess the Risk Factors, Clinical Management and Outcomes of Hospitalized Patients With Serious Infections Caused by Carbapenem-resistant Enterobacteriaceae and Acinetobacter Baumannii), which is not on this map. Cited by 56 papers, 1 of them a synthesis that pooled it.
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.
Prospective Observational Study to Assess the Risk Factors, Clinical Management and Outcomes of Hospitalized Patients With Serious Infections Caused by Carbapenem-resistant Enterobacteriaceae and Acinetobacter Baumannii
Who cites it
56 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Secondary Analysis of a Systematic Review: Are Antifungal Noninferiority Trials at Risk of Eroding Effectiveness Because of Biocreep?Antimicrobial agents and chemotherapy · 2022Pooled it
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- Trial
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- Reserve antibiotics: overcoming limitations of evidence generated from regulatory approval trials.Globalization and health · 2025Review
- Antibiotic Resistance, Susceptibility Testing and Stewardship inInternational journal of molecular sciences · 2023Review
- Article
- Pathogen-Targeted Clinical Development to Address Unmet Medical Need: Design, Safety, and Efficacy of the ATTACK Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- How widespread and convenientExpert review of gastroenterology & hepatology · 2023Review
- Retained colistin susceptibility in clinicalFrontiers in cellular and infection microbiology · 2023Article
- Desirability of outcome ranking and quality life measurement for antimicrobial research in organ transplantation.Transplant infectious disease : an official journal of the Transplantation Society · 2022Review
- A Randomized Controlled Trial of Colistin Combined with Sulbactam: 9 g per Day versus 12 g per Day in the Treatment of Extensively Drug-ResistantAntibiotics (Basel, Switzerland) · 2022Article
- Primer for Development of Guidelines for Helicobacter pylori Therapy Using Antimicrobial Stewardship.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022Review
- Article
- Discordance Among Antibiotic Prescription Guidelines Reflects a Lack of Clear Best Practices.Open forum infectious diseases · 2021Article
- Article
- Transitioning ofAntibiotics (Basel, Switzerland) · 2020Review
- Toward a structome of Acinetobacter baumannii drug targets.Protein science : a publication of the Protein Society · 2020Article
- Prognostic Utility of the New Definition of Difficult-to-Treat Resistance Among Patients With Gram-Negative Bloodstream Infections.Open forum infectious diseases · 2019Article
- Ensuring Sustainability of Needed Antibiotics: Aiming for the DART Board.Annals of internal medicine · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
Abstract
There is a critical need for new pathways to develop antibacterial agents to treat life-threatening infections caused by highly resistant bacteria. Traditionally, antibacterial agents have been studied in noninferiority clinical trials that focus on one site of infection (eg, pneumonia, intra-abdominal infection). Conduct of superiority trials for infections caused by highly antibiotic-resistant bacteria represents a new, and as yet, untested paradigm for antibacterial drug development. We sought to define feasible trial designs of antibacterial agents that could enable conduct of superiority and organism-specific clinical trials. These recommendations are the results of several years of active dialogue among the white paper's drafters as well as external collaborators and regulatory officials. Our goal is to facilitate conduct of new types of antibacterial clinical trials to enable development and ultimately approval of critically needed new antibacterial agents.
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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.