Status:
COMPLETED
Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections
Lead Sponsor:
Rabin Medical Center
Conditions:
Staphylococcal Infections
Meningitis
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
Brief Summary
Methicillin-resistant Staphylococcus aureus (SA) is a major pathogen causing mainly health-care associated infections and, lately, also community acquired infections. Few treatment choices exist to tr...
Detailed Description
Staphylococcus aureus (SA) is a major pathogen causing community-acquired and health-care associated infections. In hospitals, SA infections are associated with a significant burden; in-hospital morta...
Eligibility Criteria
Inclusion
- Adults \>18 years
- providing signed informed consent or, if unable, having a legal guardian or a caretaker that will sign informed consent
- Patients with documented MRSA infections:
- MRSA bacteremia
- Other microbiologically documented MRSA infections defined as a clinical source of infection (CDC criteria) plus microbiological documentation of MRSA from the source of infection
- Patients with highly probable MRSA infections, prior to microbiological documentation of the pathogen:
- Suspected neurosurgical meningitis (including VP-shunt meningitis)
- Sepsis during hemodialysis
- Ventilator-associated pneumonia with prior antibiotic treatment within 48 hours
- Catheter-related or suspected catheter-related infections
- Surgical site infection in the presence of a foreign body
Exclusion
- Exclusion before randomization:
- Previous antibiotic treatment directed against MRSA \>48 hours (including vancomycin, fucidic acid, rifampicin or cotrimoxazole)
- Known allergy to either study drug
- Acute leukemia and/ or BMT with neutropenia \<500/mm3 or \<1000/mm3 and expected to decrease below 500/mm3
- Pregnancy, lactation
- Previous enrollment in this study
- Concurrent participation in another trial
- Exclusions after randomization:
- Documented Staphylococcal infection resistant to cotrimoxazole or VISA or VRSA
- Documented MSSA
- Documented left-sided endocarditis
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT00427076
Start Date
June 1 2007
End Date
June 1 2014
Last Update
September 25 2015
Active Locations (2)
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1
Rambam Health Care Campus
Haifa, Israel
2
Rabin Medical Center; Beilinson Hospital and Davidoff Cancer Center
Petah Tikva, Israel, 49100