Status:
TERMINATED
Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA Bacteremia
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Novartis
Conditions:
Nosocomial Infection
Healthcare-associated Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 a...
Detailed Description
Introduction: Nosocomial and/or healthcare-associated Staphylococcus aureus infections are common, serious conditions. S. aureus accounts for about 20% of cases of nosocomial bacteremia, and is associ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01515020
Start Date
May 1 2012
End Date
July 1 2014
Last Update
August 26 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Beaujon
Clichy, France, 92118