Overview

Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA Bacteremia

Status:
Terminated
Trial end date:
2014-07-01
Target enrollment:
0
Participant gender:
All
Summary
Hypothesis: The use of daptomycin to treat nosocomial or healthcare-associated bacteremia due to methicillin-resistant S. aureus (MRSA) would increase the proportion of patients whose blood cultures are sterilized after 72 hours by 15% relative to vancomycin and would improve treatment safety. Hypothesis: for MRSA nosocomial or healthcare related bacteriemia treatment, the use of daptomycin versus vancomycin would increase by 15% the proportion of patients with sterilized blood cultures at 72 hours and would increase the treatment safety. Primary objective: To study the efficacy of daptomycin compared to vancomycin on the sterilization of blood cultures after 72 hours of therapy.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborator:
Novartis
Treatments:
Daptomycin
Methicillin
Vancomycin
Criteria
INCLUSION CRITERIA :

- Patients with nosocomial and/or healthcare-associated bacteremia with Gram-positive
cocci in clusters

- Confirmed to be meticillin-resistant S. aureus using a GeneXpert rapid molecular test

- Aged 18 years or older

- Who have given their written consent when this is possible or someone from his/her
family, or if not possible, emergency inclusion

- Who can receive follow-up for the entire duration of the study, i.e. 90 days

EXCLUSION CRITERIA :

- Known allergy to vancomycin or daptomycin

- Women who are pregnant or breast-feeding

- Patients who have received vancomycin treatment for more than 48 hours between the
diagnostic blood culture and randomization

- Specific sites of infection: pneumonia, meningitis, brain abscess, osteitis,
polymicrobial infection

- Life expectancy considered to be less than 72 hours

- Severe hepatic impairment (Child C)

- Short-term intravascular catheters which cannot be removed immediately

EXCLUSION CRITERIA between D1 and D5 inclusive :

- Specific sites of infection: osteitis diagnosed between D1 and D5 inclusive

- Permanent foreign material infection (endovascular stents, replacement heart valves or
joints, pace maker etc.) which cannot be removed within 36 hours of the first dose of
the study drug