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

Last updated: October 28, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Pneumonia

Pneumonia (Pediatric)

Treatment

Amoxicillin

Amoxicillin/clavulanate

Clinical Study ID

NCT06229288
RC20_0015
  • Ages > 65
  • All Genders

Study Summary

Reduce inappropriate antibiotic use is a priority of public health agencies. Community-acquired pneumonia (CAP) is one of the most important indications for antibiotic prescriptions.

In the majority of the studies of CAP, there is a large proportion of cases with no pathogen identified. Thus, the choice of the empirical antibiotic depends on the most likely pathogen, individual risk factors, comorbidities, and allergies.

Patients aged 65 years or older are often treated with amoxicillin/clavulanate or with another broad-spectrum antibiotic (third-generation cephalosporins, antipneumococcal fluoroquinolone). However, broad-spectrum antibiotic prescription in CAP is debated and concerns exist about side-effects and selective pressure for resistance. Due to lack of head-to-head antibiotic comparisons, a recent Cochrane review concluded that current evidence from Randomized Clinical Trials (RCTs) is insufficient to make evidence-based recommendations for the choice for antibiotic to be used, highlighting an important evidence gap.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient aged 65 years or older with or without comorbidities defined by chronicdiseases in immunocompetent patients,

  2. 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

  3. Patient understanding oral and written French

  4. 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).

  5. 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:

  1. Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratoryinsufficiency, ICU admission)

  2. Patient requiring ICU admission,

  3. Estimated Glomerular Filtration Rate < 30 ml/min,

  4. Known immunosuppression (asplenia, neutropenia, agammaglobulinemia, transplant,myeloma, lymphoma, known HIV and CD4<200/mm3),

  5. Exacerbation of chronic obstructive pulmonary disease,

  6. Life-threatening state expected to lead to possible imminent death,

  7. Suspected atypical bacteria requiring combined antibiotics therapy,

  8. Legionella suspected,

  9. Subjects with clinical or epidemiological environment leading to suspect ahealthcare associated pneumonia with antibiotic resistant pathogen (includinglong-term care facility)

  10. Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae inthe respiratory tract,

  11. Suspicion of aspiration pneumonia,

  12. Administration of any antibiotic treatment for more than 24 hours before inclusion,

  13. History of jaundice/hepatic impairment associated with amoxicillin/clavulanate acid,

  14. History of bacterial pneumonia less than 1 month prior to study inclusion

  15. History of hypersensitivity or allergy to beta-lactam or to any excipients includedin study antibiotics,

  16. Subject without health insurance,

  17. Subject without home address or difficulty in terms of follow-up (vacation, jobtransfer, geographical distance, lack of motivation),

  18. Patient under judicial protection,

  19. Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, chestcomputed tomography (CT) scan),

  20. 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

Total Participants: 326
Treatment Group(s): 2
Primary Treatment: Amoxicillin
Phase: 3
Study Start date:
April 25, 2024
Estimated Completion Date:
May 25, 2027

Study Description

Thus, the goal of the proposed trial is to compare clinical efficacy and safety of two CAP antimicrobial treatments, amoxicillin and amoxicillin/clavulanate, in patients aged 65 years or older and hospitalized in a non-intensive care unit (ICU) ward. The CAPTAIN study will be a multi-center, randomized, open, non-inferiority trial comparing clinical efficacy at Day 30 among patients ≥65 years of age, and hospitalized in a non-ICU ward, treated with narrow-spectrum (amoxicillin) versus broad-spectrum (amoxicillin/clavulanate) antimicrobial therapy for CAP. This will be a pivotal clinical trial that will provide evidence to inform CAP treatment guidelines.

Connect with a study center

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • Chu Angers

    Angers,
    France

    Active - Recruiting

  • CHU Avicenne AP-HP

    Bobigny,
    France

    Active - Recruiting

  • CHRU Brest

    Brest,
    France

    Active - Recruiting

  • CHD Vendée

    La Roche-sur-Yon,
    France

    Active - Recruiting

  • CHU Grenoble-Alpes

    La Tronche,
    France

    Active - Recruiting

  • Assistance Publique Hopitaux De Marseille

    Marseille,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • CH Perigueux

    Perigueux,
    France

    Active - Recruiting

  • CHRU - TOULOUSE Hôpital Purpan

    Toulouse,
    France

    Active - Recruiting

  • CHRU TOULOUSE - Hôpital Rangueuil

    Toulouse,
    France

    Active - Recruiting

  • Centre Hospitalier Bretagne Atlantique

    Vannes,
    France

    Active - Recruiting

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