Actively Recruiting
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-03-20
328
Participants Needed
1
Research Sites
N/A
Total Duration
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 physician's 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
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 48 hours up to 10 days depending on clinical response and physician's decision
Participants receive antibiotic treatment for community-acquired pneumonia, with duration customized based on clinical stability or physician judgment.
Visits at treatment initiation and as needed until treatment completion
Duration - Up to 30 days after treatment initiation
Participants are monitored for cure, symptom evolution, adverse events, and antibiotic resistance after treatment completion.
Visits at Day 7, Day 15, and Day 30
Total: 1 location
1
Infectious diseases department, Raymond-Poincaré Hospital - APHP
Garches, France, 92380
Actively Recruiting
A
Aurélien Dinh, MD, PhD
J
Jacques Ropers, PharmD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Aurélien Dinh, Jacques Ropers, Clara Duran...
https://pubmed.ncbi.nlm.nih.gov/33773631