Status:
COMPLETED
Efficacy of Daptomycin Plus Fosfomycin Versus Daptomycin for Treatment of MRSA Bacteremia
Lead Sponsor:
Miquel Pujol
Collaborating Sponsors:
Hospital Universitari de Bellvitge
Conditions:
Staph Aureus Methicillin Resistant Bacteremia
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
To demonstrate that the combination of daptomycin and fosfomycin is superior to daptomycin alone in the treatment of methicillin resistant Staphylococcus aureus (MRSA) bacteremia.
Detailed Description
The mortality associated to MRSA bacteremia remains higher than 30% of episodes despite the availability of new antibiotics. Objective: To demonstrate that the combination of daptomycin and fosfomycin...
Eligibility Criteria
Inclusion
- Patients with at least 1 positive blood culture to MRSA within 72h up to randomization
- Adult patients, equal or older than 18 years old
- Signed informed consent
- Mandatory use of contraception methods for fertile women during the study period and for 6 months after stopping antibiotic therapy
Exclusion
- Polymicrobial bacteremia
- Pneumonia associated to the bacteremia
- Severe clinical status with expected survival of less than 24 hours
- Allergy to daptomycin or fosfomycin
- A positive pregnancy test at the time of inclusion
- Any clinical condition that requires additional antibiotic therapy with microbiological activity against MRSA
- Patient already included in another clinical trial
- Prior history of eosinophilic pneumonia
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2018
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT01898338
Start Date
December 1 2013
End Date
January 10 2018
Last Update
January 17 2018
Active Locations (18)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
2
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
3
Hospital Universitari Mútua de Terrassa
Terrassa, Barcelona, Spain, 08221
4
Hospital de Terrassa
Terrassa, Barcelona, Spain, 08227