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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

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 the efficacy of our experimental strategy on antibiotic treatment duration compared to standard of care in CAP patients treated in the hospital setting is non-inferior in terms of:

* Persistence of cure at Day 30 of antibiotic treatment * All-cause mortality rate on Day 30 of antibiotic treatment * Patients evolution of pneumonia symptoms and quality of life via 2 scores (CAP score, CAP Sym) at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7 , at Day 15, and at Day 30 of antibiotic treatment. * To compare between the 2 study arms at Day 30 of antibiotic treatment:

* The duration of antibiotic treatment; * The length of hospital stay; * The frequency and severity of adverse events during the 30 days after the start of treatment. * To explore the impact of reduced antibiotic treatment duration for CAP on the oropharyngeal resistome.

Eligibility criteria

Qualifiers

Adult patient (≥18 years old)

Fever (temperature > 38°C) or hypothermia (< 36°C)

Dyspnea

Cough

Disqualifiers

Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency)

Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3)

Suspected or confirmed legionellosis

Any other infection necessitating concomitant antibiotic treatment

Trial design

Treatments tested in this trial

  • Stop antibiotic
  • Continue the antimicrobial treatment

Treatment groups

328 Participants
are divided into 2 treatment groups