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

NCT05117398 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2025-04-06

No results posted yet for this study

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).

Conditions

  • Catheter Bacteremia
  • Staphylococcus Aureus Infection

Interventions

DRUG

Dalbavancin 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.

DRUG

Standard 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).

Sponsors & Collaborators

  • Centre Hospitalier de Perigueux

    collaborator OTHER

  • Advanz Pharma

    collaborator INDUSTRY

  • Nantes University Hospital

    collaborator OTHER

  • Centre National de Référence des staphylocoques

    collaborator UNKNOWN

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Bernard CASTAN, MD · CH de Perigueux

  • Aurélien DINH, MD, PhD · APHP - RAYMOND POINCARE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2025-09-23
Completion
2026-09-23

Countries

  • France

Study Locations

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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 NCT05117398 on ClinicalTrials.gov