CUSTOMIZED ANTIBIOTIC TREATMENT DURATION AMONG HOSPITALIZED PATIENTS WITH MODERATELY SEVERE COMMUNITY-ACQUIRED PNEUMONIA [CAT-CAP]
- Conditions
- Community-acquired pneumoniaTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- CTIS2023-504208-27-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 424
Adult patient (=18 years old), Negative viral respiratory testing (positive viral testing will be allowed only if bacterial documentation is confirmed by PCR or culture), Antibiotic treatment anticipated to be prescribed for a minimum of one additional day if the patient is not randomized into the experimental group, Admitted to hospital for suspected CAP defined by the presence of at least 2 of the following diagnostic clinical criteria: oFever (temperature > 38°C) or hypothermia (< 36°C) oDyspnea oCough oProduction of purulent sputum oCrackles, Radiological evidence of a new infiltrate (chest X-ray or CT scan), Treated for a minimum of 48 hours and a maximum of 7 days with antibiotics chosen according to the French recommendations for suspected CAP (excluding azithromycin due to its prolonged half-life) and 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: oapyrexia (T°C = 37.8) oheart rate < 100/min orespiratory rate < 24/min, according to the patient's usual mode of oxygenation, oarterial oxygen saturation = 92%, according to the patient's usual mode of oxygenation, osystolic blood pressure = 90mmHg, The last occurring of these criteria must have appeared within the last 24 hours., No other site of infection besides respiratory, Affiliated to Health insurance or patients with government medical aid called AME, 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 (Patient should be able to call and to answer to a phone call or to be with a relative who can help him to call or to answer questions notably raised by medical staff belonging to the investigational site), Patient presenting a 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/min, respiratory rate < 24/min, arterial oxygen saturation = 90% on room air, systolic blood pressure = 90mmHg
Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency insufficiency with long-term oxygen therapy, ICU admission), Patient enrolled in another interventional clinical trial on antibiotic treatments, Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, bone marrow transplant, myeloma, lymphoma, known HIV and CD4<200/mm3), Suspected or confirmed legionellosis, Any other infection necessitating concomitant antibiotic treatment (except if treated by oral fosfomycin, furadantin and pivmecillinam used in accordance with the marketing authorisations), Confirmed aspiration pneumonia or healthcare-associated pneumonia, Contra-indications to study antibiotics, Patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (for patients treated with fluoroquinolones), History of bacterial pneumonia less than 1 month prior to study inclusion, Bronchopulmonary diseases : cystic fibrosis; severe bronchiectasis; lung cancer; ongoing tuberculosis or major sequelae of tuberculosis, Treatment of suspected CAP with azithromycin (due to its prolonged half-life), Concomitant steroid treatment (only for patients treated with fluoroquinolones antibiotics), Pregnant or breastfeeding woman, More than 24 hours of antibiotics prior to hospital admission (except for oral fosfomycin, furadantin and pivmecillinam used in accordance with the marketing authorisations), Positive family history of aneurysm disease or congenital heart valve disease, patients diagnosed with pre-existing aortic aneurysm and/or dissection or heart valve disease, patients with presence of other risk factors or conditions predisposing: for both aortic aneurysm and dissection and heart valve regurgitation/incompetence (e.g. connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome, Turner syndrome, Behcet´s disease, hypertension, rheumatoid arthritis) or additionally .for aortic aneurysm and dissection (e.g. vascular disorders such as Takayasu arteritis or giant cell arteritis, or known atherosclerosis, or Sjögren’s syndrome) or additionally .for heart valve regurgitation/incompetence (only for patients treated with fluoroquinolones antibiotics), Life expectancy < 1 month, Patient under legal guardianship (French tutelle” or curatelle”), Patient without fixed address
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method