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ClinicalTrials.gov ID

NCT06229288

Lead Sponsor

Nantes University HospitalOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

326Estimated

Last Update Posted

Apr 8, 2026Actual

Start Date

Apr 25, 2024Actual

Primary Completion Date

May 25, 2027Estimated

Completion Date

May 25, 2027Estimated

Official Title

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

Brief 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.

Detailed 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.

• Community-acquired Pneumonia

• Amoxicillin
• Amoxicillin/clavulanate

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

1. Patient aged 65 years or older with or without comorbidities defined by chronic diseases in immunocompetent patients,
2. 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 had 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 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:

1. Signs of severe CAP (abscess, massive pleural effusion, serious chronic respiratory insufficiency, 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 a healthcare associated pneumonia with antibiotic resistant pathogen (including long-term care facility)
10. Patient known to be colonized with Pseudomonas aeruginosa or Enterobacteriaceae in the 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 included in study antibiotics,
16. Subject without health insurance,
17. Subject without home address or difficulty in terms of follow-up (vacation, job transfer, geographical distance, lack of motivation),
18. Patient under judicial protection,
19. Diagnosis confirmed of SAR-Cov2 infection (PCR Test, covid antigen rapid test, chest computed tomography (CT) scan),
20. 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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Nantes University HospitalOTHER

delphine.plard@chu-angers.fr0241353637 ext. +33

rafael.mahieu@chu-angers.fr0241353930 ext. +33

sylvain.jaffuel@chu-brest.fr0298347213 ext. +33

rozenn.leberre@chu-brest.fr029822333 ext. +33

emmanuel.montassier@chu-nantes.fr0253482038 ext. +33