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ID05903352

Personalized Antibiotic Treatment Duration for Adults Hospitalized with Moderate Community-Acquired Pneumonia A Phase 3 Trial Comparing Customized and Standard Therapy Lengths

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-20

328

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new approach to antibiotic treatment duration for patients hospitalized with moderately severe community-acquired pneumonia CAP. The study aims to determine if stopping antibiotics when specific stability criteria are met after at least 48 hours of treatment is as effective as the standard treatment duration. This phase III randomized trial also examines symptom evolution, quality of life, mortality, hospital stay length, adverse events, and antibiotic resistance. Participants are randomly assigned to one of two groups one group receives antibiotic treatment determined by the physicians usual practice, typically lasting 5 to 10 days, while the other group stops antibiotic treatment once stability criteria are reached, but not before 48 hours. Stability criteria include normal body temperature, heart rate, blood pressure, oxygen saturation, respiratory rate, and mental status. The study does not involve a placebo and uses standard antibiotic treatments. Participants will undergo evaluations of pneumonia symptoms and quality of life at multiple time points at treatment start Day 0, at stability Day S, and on Days 7, 15, and 30. Researchers will monitor the rate of cure at Day 15 primary outcome, as well as cure persistence, mortality, treatment duration, hospital stay length, adverse events, and antibiotic resistance genes up to Day 30. The total duration of participation depends on these assessments, with safety and treatment response closely observed throughout the study period.

CONDITIONS

Brief Title

Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia

Research Team

A

Aurélien Dinh, MD, PhD

J

Jacques Ropers, PharmD

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