MedTrace Logo

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

NCT06203769 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2024-01-12

No results posted yet for this study

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.

Conditions

  • Cardiac Devices Infection

Interventions

DRUG

14-day antibiotic therapy

The studied intervention will be 14-day antibiotic therapy after removal of infected material

DRUG

28-day antibiotic therapy

The comparator arm will be 28-day antibiotic therapy after removal of infected material

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2028-01-30
Completion
2028-06-30

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06203769 on ClinicalTrials.gov