Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
Recruiting
Phase 3
Interventional Study
Community-Acquired Pneumonia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 328 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
The primary objective of the study is to evaluate if the efficacy of an experimental strategy on antibiotic treatment duration based on stopping treatment when stability criteria are reached after at least 48 h of treatment, is non-inferior to the efficacy of standard antibiotic duration in CAP patients treated in the hospital setting.
As the secondary objectives, the study aims
* To study if th…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Adult patient (≥18 years old)
* Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria:
* Fever (temperature \> 38°C) or hypothermia (\< 36°C)
* Dyspnea
* Cough
* Production of purulent sputum
* Cra…
Contacts