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

Name: Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices Leads — clinical trial record (NCT06203769)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Study acronym: RAID

StatusNot Yet Recruiting

PhasePhase 4

SponsorAssistance Publique - Hôpitaux de Paris

Started2024-06-30

View on ClinicalTrials.gov ↗

Assistance Publique - Hôpitaux de Paris

1,338 trials monitored

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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