Phase
Condition
Pneumonia
Pneumonia (Pediatric)
Treatment
Amoxicillin
Amoxicillin/clavulanate
Clinical Study ID
Ages > 65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient aged 65 years or older with or without comorbidities defined by chronicdiseases in immunocompetent patients,
Patient admitted to the hospital for a CAP defined by at least two clinical signs ofpneumonia (cough, sputum production, dyspnea, tachypnea, or pleuritic pain, abnormallung auscultatory sounds, fever (temperature > 38°C) or hypothermia (<36°C)), andhad radiological evidence of a new infiltrate confirming pneumonia
Patient understanding oral and written French
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).
Patients should be able to call and to answer to a phone call or to be with arelative who can help him to call or to answer questions notably raised by a medicalstaff belonging to the investigational site
Exclusion
Exclusion Criteria:
Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratoryinsufficiency, ICU admission)
Patient requiring ICU admission,
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 state expected to lead to possible imminent death,
Suspected atypical bacteria requiring combined antibiotics therapy,
Legionella suspected,
Subjects with clinical or epidemiological environment leading to suspect ahealthcare associated pneumonia with antibiotic resistant pathogen (includinglong-term care facility)
Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae inthe respiratory tract,
Suspicion of aspiration pneumonia,
Administration of any antibiotic treatment for more than 24 hours before inclusion,
History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid,
History of bacterial pneumonia less than 1 month prior to study inclusion
History of hypersensitivity or allergy to beta-lactam or to any excipients includedin study antibiotics,
Subject without health insurance,
Subject without home address or difficulty in terms of follow-up (vacation, jobtransfer, geographical distance, lack of motivation),
Patient under judicial protection,
Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, chestcomputed tomography (CT) scan),
Participation to another interventional study and having an exclusion period that isstill in force during the screening phase or expected participation to anotherinterventional study during participation to the CAPTAIN study
Study Design
Study Description
Connect with a study center
CHU Angers
Angers,
FranceActive - Recruiting
Chu Angers
Angers,
FranceActive - Recruiting
CHU Avicenne AP-HP
Bobigny,
FranceActive - Recruiting
CHRU Brest
Brest,
FranceActive - Recruiting
CHD Vendée
La Roche-sur-Yon,
FranceActive - Recruiting
CHU Grenoble-Alpes
La Tronche,
FranceActive - Recruiting
Assistance Publique Hopitaux De Marseille
Marseille,
FranceActive - Recruiting
CHU de Nantes
Nantes,
FranceActive - Recruiting
CH Perigueux
Perigueux,
FranceActive - Recruiting
CHRU - TOULOUSE Hôpital Purpan
Toulouse,
FranceActive - Recruiting
CHRU TOULOUSE - Hôpital Rangueuil
Toulouse,
FranceActive - Recruiting
Centre Hospitalier Bretagne Atlantique
Vannes,
FranceActive - Recruiting
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