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