Clinical Trial

Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices Leads

Study acronym: RAID
Not Yet Recruiting Phase 4
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Summary
The design is an Open-label randomized controlled multicenter non-inferiority trial with blinded assessor which compares 2 antibiotic strategy: 14-day antibiotic therapy after removal of infected material (experimental group) versus 28-day antibiotic therapy after removal of infected material (control group). Randomization will be centralized, individual 1:1, stratified on center and age (\<75 versus \>=75 years). Analysis will be reported following CONSORT guidelines for pharmacological trials. Main analysis will be conducted according to per protocol and intent-to-treat principles. Subgroup analysis will be conducted according to age, classes of antibiotics at baseline and according to resistance testing and baseline renal clearance.
Trial Details
NCT Number NCT06203769
Lead Sponsor Assistance Publique - Hôpitaux de Paris
Conditions Cardiac Devices Infection
Enrollment 500 participants
Start Date 2024-06-30
Primary Completion 2028-01-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-01-12