NOT YET RECRUITING
NCT06203769
Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices Leads
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.
Gender: All
Ages: 18 Years - Any
Cardiac Devices Infection