Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229288
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2024-01-10
Brief Title:
Amoxicillin Alone Versus AmoxicillinClavulanate for Community-acquired Pneumonia in Patients Aged 65 Years or Older and Hospitalized in a Non-intensive Care Unit Ward
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Amoxicillin Alone Versus AmoxicillinClavulanate 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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPTAIN
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 amoxicillinclavulanate 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
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 amoxicillinclavulanate 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 amoxicillinclavulanate 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 amoxicillinclavulanate antimicrobial therapy for CAP This will be a pivotal clinical trial that will provide evidence to inform CAP treatment guidelines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None