Clinical Research Directory
Browse clinical research sites, groups, and studies.
Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices Leads
Sponsor: Assistance Publique - Hôpitaux de Paris
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.
Official title: Reduction of Antibiotherapy Duration for Infections on Implantable Extra Cardiac Devices Leads: a Randomized Controlled Multicenter Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
500
Start Date
2024-06-30
Completion Date
2028-06-30
Last Updated
2024-01-12
Healthy Volunteers
No
Conditions
Interventions
14-day antibiotic therapy
The studied intervention will be 14-day antibiotic therapy after removal of infected material
28-day antibiotic therapy
The comparator arm will be 28-day antibiotic therapy after removal of infected material