Amoxicillin alone versus amoxicillin/clavulanate for community-acquired pneumonia in patients aged 65 years or older, and hospitalized in a non-intensive care unit ward: a non-inferiority randomized controlled trial _ CAPTAI

Phase 1

Recruiting

• Conditions: Patients aged 65 years or older, hospitalized in a non-ICU ward for a community acuquired pneumonia, and treated with narrow-spectrum versus broad-spectrum antimicrobial therapy; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: CTIS2023-503645-63-00
• Lead Sponsor: Centre Hospitalier Universitaire De Nantes

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-25
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients, Patient admitted to the hospital for a CAP defined by at least two clinical signs of pneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormal lung auscultatory sounds, fever (temperature > 38°C) or hypothermia (< 36°C)) and radiological evidence of a new infiltrate confirming pneumonia, Written informed consent obtained from patient prior to participation in the study (if the patient is unable to express in writing: consent by a trusted person), Patient understanding oral and written French, Patients 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 a medical staff belonging to the investigational site

Exclusion Criteria

Patient requiring ICU admission, Subjects with clinical or epidemiological environment leading to suspect a healthcare associated pneumonia with antibiotic resistant pathogen (including long-term care facility), Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae in the respiratory tract, Suspicion of aspiration pneumonia, Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, ICU admission), History of bacterial pneumonia less than 1 month prior to study inclusion, History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid, History of hypersensitivity or allergy to beta-lactam or to any excipients included in study antibiotics, Subject without health insurance, Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation), Patient under judicial protection, Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, or chest computed tomography (CT) scan), Administration of any antibiotic treatment for more than 24 hours before inclusion, Participation to another interventional study and having an exclusion period that is still in force during the screening phase or expected participation to another interventional study during participation to the CAPTAIN study, Estimated Glomerular Filtration Rate < 30 ml/min, Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant, myeloma, lymphoma, known HIV and CD4<200/mm3), Exacerbation of chronic obstructive pulmonary disease, Life-threatening presentation expected to lead to possible imminent death, Suspected atypical bacteria requiring combined antibiotics therapy, Legionella suspected

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified