Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices Leads
Status:
NOT_YET_RECRUITING
Trial end date:
2028-06-30
Target enrollment:
Participant gender:
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.