ReviewClinical infectious diseases : an official publication of the Infectious Diseases Society of America2012
Progress on developing endpoints for registrational clinical trials of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections: update from the Biomarkers Consortium of the Foundation for the National Institutes of Health.
Review 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. Cited by 36 papers, 3 of them syntheses 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
36 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- The impact of antibiotics on clinical response over time in uncomplicated cellulitis: a systematic review and meta-analysis.Infection · 2022Pooled it
- Systematic Review and Meta-Analysis To Estimate Antibacterial Treatment Effect in Acute Bacterial Skin and Skin Structure Infection.Antimicrobial agents and chemotherapy · 2015Pooled it
- Systematic review and meta-analysis of linezolid and daptomycin for treatment of vancomycin-resistant enterococcal bloodstream infections.Antimicrobial agents and chemotherapy · 2013Pooled it
- Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin Structure Infections.Open forum infectious diseases · 2026Trial
- Early Clinical Response in Community-acquired Bacterial Pneumonia: From Clinical Endpoint to Clinical Practice.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2019Trial
- Early improvement in severely ill patients with pneumonia treated with ceftobiprole: a retrospective analysis of two major trials.BMC infectious diseases · 2019Trial
- Early Clinical Assessment of the Antimicrobial Activity of Finafloxacin Compared to Ciprofloxacin in Subsets of Microbiologically Characterized Isolates.Antimicrobial agents and chemotherapy · 2018Trial
- Safety, tolerability, and efficacy of GSK1322322 in the treatment of acute bacterial skin and skin structure infections.Antimicrobial agents and chemotherapy · 2014Trial
- Comparison of digital planimetry and ruler technique to measure ABSSSI lesion sizes in the ESTABLISH-1 study.Surgical infections · 2014Trial
- Phase II clinical study of BC-3781, a pleuromutilin antibiotic, in treatment of patients with acute bacterial skin and skin structure infections.Antimicrobial agents and chemotherapy · 2013Trial
- Determinants of treatment outcomes among hospitalised patients with skin and soft tissue infections: a prospective observational study.BMJ open · 2026Observational
- Vitamin C Supplementation in Hospitalized Patients With Community-Acquired Pneumonia: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2026Article
- Understanding Early and Late Endpoints in Registrational Trials of Community-acquired Bacterial Pneumonia.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Article
- Health-Related Quality of Life as Measured by the 36-Item Short Form Survey Among Adults With Acute Bacterial Skin and Skin Structure Infections who Received Either Omadacycline or Linezolid in a Phase 3 Double-Blind, Double-Dummy Clinical Trial.Open forum infectious diseases · 2021Article
- Health-Related Quality of Life as Measured by the 12-Item Short-Form Survey Among Adults With Community-Acquired Bacterial Pneumonia who Received Either Lefamulin or Moxifloxacin in 2 Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials.Open forum infectious diseases · 2020Article
- Article
- Evidence-Based Study Design for Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia.The Journal of infectious diseases · 2019Article
- The Foundation for the National Institutes of Health Biomarkers Consortium: Past Accomplishments and New Strategic Direction.Clinical pharmacology and therapeutics · 2019Article
- When antibiotic treatment fails.Intensive care medicine · 2018Article
- Progress in the Fight Against Multidrug-Resistant Bacteria 2005-2016: Modern Noninferiority Trial Designs Enable Antibiotic Development in Advance of Epidemic Bacterial Resistance.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2017Review
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
Efficacy endpoints for previous registrational trials of antimicrobials for acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia (CABP) were based on nonstandardized, clinician-based observations and decisions, as well as on patient reports. More quantifiable, reproducible, and externally verifiable endpoints could improve the design of future noninferiority trials. At the request of the Food and Drug Administration, the Foundation for the National Institutes of Health convened a broadly representative scientific project team to evaluate potential endpoints for such registrational trials. Review of historical and modern data led to the conclusion that antimicrobial treatment effects are most apparent early in therapy; later outcomes provide important supportive information. Although evidence is incomplete, early response endpoints can anchor noninferiority hypotheses in ABSSSI and CABP registrational trials, thereby allowing evidence-based drug development to continue. Further research is underway to establish which short- and long-term outcomes are well-defined, reliable, and reflective of how patients feel, function, or survive.
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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.