RecruitingPhase 3NCT05117398

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

Randomized Open-label Controlled Trial Evaluating a Single-dose Intravenous Dalbavancin Versus Standard Antibiotic Therapy During Catheter-related Bloodstream Infections Due to Staphylococcus Aureus


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

406 participants

Start Date

Jun 23, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of the study is to demonstrate, among patients with non-complicated CR-BSIs due to S. aureus, that a single-dose of intravenous (IV) dalbavancin 1500 mg is non-inferior to standard documented antibiotic therapy for 14 days according to national guidelines at DAY 30 (Long follow up visit). As the secondary objectives, the study aims to evaluate according to treatment group: 1. Cure rate at DAY 14 and DAY 90 (EOS); 2. Mortality rate within 90 days of follow-up; 3. Time to negativation of blood cultures; 4. Patient's quality of life; 5. Hospitalization length of stay; 6. Cost-utility analyses; 7. Occurrence of any adverse event (AE and SAE), until Day 90 (EOS).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dalbavancin administration and a drug called Standard antibiotic therapy for people with catheter bacteremia and staphylococcus aureus infection. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDalbavancin administration

A single-dose of intraveneuse (IV) administration of dalbavancin of 1500 mg. In case of patients with chronic renal impairment (creatinin clairance \< 30mL/min), a single-dose of IV administration of reduced dalbavancin of 1000 mg.

DRUGStandard antibiotic therapy

Standard Antibiotic therapy according to national recommendations. During the study, the start of treatment is considered to be the day of inclusion/randomization (even if active antiobiotic treatment was started, less than 72 hours ago according to inclusion criteria).


Locations(2)

Infectious Diseases Department, Raymond-Poincaré Hospital - APHP

Garches, France

Infectious Diseases Department, CH PERIGUEUX

Périgueux, France

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NCT05117398


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