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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

Study acronym: CAPTAIN
StatusRecruiting
PhasePhase 3
Started2024-04-25
View on ClinicalTrials.gov ↗

Amendment history

2026-04-02
minor
Study Status, Contacts/Locations v4
Study sitesdetails revised at 2 of 19 sites
2026-01-23
minor
Study Status, Outcome Measures, Contacts/Locations v3
Secondary endpoints11 to 12 entries
Analysis of sensitivity todiscordance
2025-11-24
minor
Study Status, Contacts/Locations v2
Study sites17→19
2024-10-28
notable
Not Yet Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-04-15→2027-05-25
Completion date2027-04-15→2027-05-25
Start dateestimated 2024-03-15→confirmed 2024-04-25
Study sites0→17
Eligibility criteria-50 characters
[...] n the respiratory tract, Suspicion of aspiration pneumonia, IntercurrentAdministration infectionof requiringany antibiotic treatment, Administration of beta-lactam therapy for more than 24 hours before inclusion, History of jaundic [...]
2024-01-19
minor
Original filing
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.
Trial Details
NCT Number NCT06229288
Lead Sponsor Nantes University Hospital
Conditions Community-acquired Pneumonia
Enrollment 326 participants
Start Date 2024-04-25
Primary Completion 2027-05-25 (estimated)
Study Completion 2027-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-04-08