drugset / Trial / NCT05117398
Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus
Phase 3
Recruiting
406 enrolled
Assistance Publique - Hôpitaux de Paris
Advanz Pharma · collabCentre Hospitalier de Perigueux · collabCentre National de Référence des staphylocoques · collabNantes University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2023-06-23
- Primary completion
- 2025-09-23
- Completion
- 2026-09-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalbavancin | Other / unclassified | 1000 mg | Intravenous |
| Subject | Dalbavancin | Other / unclassified | 1500 mg | Intravenous |