Informations générales (source: ClinicalTrials.gov)
Customized Antibiotic Treatment Duration Among Hospitalized Patients With Moderately Severe Community-Acquired Pneumonia
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2024
mai 2027
10 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | DINH Aurelien | 13/12/2025 07:37:52 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 13/12/2025 07:37:54 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Beaujon | |||||
| AP-HP - Hôpital Bicêtre | |||||
| AP-HP - Hôpital Bichat | |||||
| AP-HP - Hôpital Europeen Georges Pompidou | |||||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | |||||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | |||||
| AP-HP - Hôpital Paul Brousse | |||||
| AP-HP - Hôpital Raymond Poincaré | |||||
| AP-HP - Hôpital Saint Antoine | |||||
| AP-HP - Hôpital Saint Louis | |||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Infectious diseases department, Raymond-Poincaré Hospital - APHP - 92380 - Garches - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- Crackles
- Radiological evidence of a new infiltrate (chest X-ray or CT scan)
- Negative viral respiratory testing
- Treated for a minimum of 48 hours with antibiotics (excluding azithromycin due to
its prolonged half-life)Presenting with an early clinical response within the last
24 hours (up to 7 days after the start of antibiotic treatment, if planned treatment
duration > 7 days), defined by the presence of all the following criteria:apyrexia
(T°C ≤ 37.8)heart rate < 100/minrespiratory rate < 24/min, according to the
patient's usual mode of oxygenation,arterial oxygen saturation ≥ 92%, according to
the patient's usual mode of oxygenation,Patient currently under antibiotic treatment
for his suspected CAP (i.e. the last dose of ATB has been administered to the
patient less than 24 hours ago)
- Patient presenting a clinical response within the last 24 hours defined by the
presence of all the following criteria:
- apyrexia (T°C ≤ 37.8)
- heart rate < 100/min
- respiratory rate < 24/min, according to the patient's usual mode of
oxygenation,
- arterial oxygen saturation ≥ 92%, according to the patient's usual mode of
oxygenation,
- systolic blood pressure ≥ 90mmHg, The last occurring of these criteria must
have appeared within the last 24 hours.
- The antibiotic treatment for suspected CAP has started at least 48 hours ago and at
most 6 days ago
- No other site of infection besides respiratory
- Affiliated to Health insurance
- Has given informed consent
- Patient understanding oral and written French, or presence of a relative who can
explain and help him complete the study documents
- 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
- Crackles
- Radiological evidence of a new infiltrate (chest X-ray or CT scan)
- Negative viral respiratory testing
- Treated for a minimum of 48 hours with antibiotics (excluding azithromycin due to
its prolonged half-life)Presenting with an early clinical response within the last
24 hours (up to 7 days after the start of antibiotic treatment, if planned treatment
duration > 7 days), defined by the presence of all the following criteria:apyrexia
(T°C ≤ 37.8)heart rate < 100/minrespiratory rate < 24/min, according to the
patient's usual mode of oxygenation,arterial oxygen saturation ≥ 92%, according to
the patient's usual mode of oxygenation,Patient currently under antibiotic treatment
for his suspected CAP (i.e. the last dose of ATB has been administered to the
patient less than 24 hours ago)
- Patient presenting a clinical response within the last 24 hours defined by the
presence of all the following criteria:
- apyrexia (T°C ≤ 37.8)
- heart rate < 100/min
- respiratory rate < 24/min, according to the patient's usual mode of
oxygenation,
- arterial oxygen saturation ≥ 92%, according to the patient's usual mode of
oxygenation,
- systolic blood pressure ≥ 90mmHg, The last occurring of these criteria must
have appeared within the last 24 hours.
- The antibiotic treatment for suspected CAP has started at least 48 hours ago and at
most 6 days ago
- No other site of infection besides respiratory
- Affiliated to Health insurance
- Has given informed consent
- Patient understanding oral and written French, or presence of a relative who can
explain and help him complete the study documents
- 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
- Confirmed or suspected aspiration pneumonia or healthcare-associated pneumonia
- Treatment of suspected CAP with azithromycin (due to its prolonged half-life)
- Concomitant steroid treatment (only for patients treated with fluoroquinolones
antibiotics)
- Pre-existing aortic aneurysm or dissection, family history of aortic aneurysm or
dissection, Marfan syndrome, Ehlers-Danlos syndrome, Takayasu arthritis,
uncontrolled arterial hypertension, atherosclerosis (only for patients treated with
fluoroquinolones antibiotics)
- Pregnant or breastfeeding woman
- Life expectancy < 1 month
- Patient under legal guardianship (French "tutelle" or "curatelle")
- Patient without fixed address
- Patient enrolled in another interventional clinical trial on CAP treatment