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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Stop antibiotic
Other interventionStop the antibiotic treatment on day S (stability criteria reached for 24 h or within 48 hours after the start of antibiotic treatment).
Continue the antimicrobial treatment
DrugContinue the antimicrobial treatment for a duration predetermined by the investigator (usual practice, at least 5 days of treatment in total).
Treatment groups
Trial outcomes
Primary outcomes
Rate of cure at Day 15 after treatment initiation
Cure at Day 15 will be defined by the association of: * Persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure \> 90mmHg; oxygen saturation ≥ 92%; respiratory rate \< 24/min; normal mental status); * No additional antibiotic treatment, targeting CAP, taken after the end of initial antibiotic treatment. Patients who died, or are not cured as defined above, will be classified as failure at Day 15.
Secondary outcomes
Rate of cure at Day 30
Rate of cure at Day 30 after the start of treatment defined by the association of: persistence of stability criteria (body temperature ≤ 37.8°C; heart rate ≤ 100/min; systolic blood pressure \> 90mmHg; O2 saturation ≥ 92%; respiratory rate \< 24/min; normal mental status); absence of additional antibiotic treatment needed after the end of initial antibiotic treatment.
Mortality on Day 30
All-cause mortality on Day 30 after the start of antibiotic treatment.
Patients' evolution of pneumonia symptoms
Patients' evolution of pneumonia symptoms by CAP Score at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7, at Day 15, and at Day 30 of antibiotic treatment.
Patients' evolution of pneumonia symptoms
Patients' evolution of pneumonia symptoms and quality of life by CAP Sym: validated self-questionnaires filled at Day 0 of treatment (retrospectively), at stability (Day S), at Day 7, at Day 15, and at Day 30 of antibiotic treatment.
Sponsors and contacts
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