Cotrimoxazole Versus Vancomycin for Invasive Methicillin-resistant Staphylococcus Aureus Infections
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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 treat these infections. The currently recommended antibiotics for
these infections are glycopeptides (vancomycin or teicoplanin). Glycopeptide treatment hs
several disadvantages. It is a last resort antibiotic family that should be reserved for the
future; Vancomycin is less effective that beta-lactam drugs for SA infections susceptible to
both agents; treatment can only be given intravenously; and use of vancomycin has led to the
development of SA strains with partial or complete resistance to vancomycin. Cotrimoxazole is
an old antibiotic active against most strains of MRSA, depending on local epidemiology.
Study hypothesis: The purpose of this study is to show that cotrimoxazole is as effective as
treatment with vancomycin for invasive MRSA infections.
We plan a randomized controlled trial comparing treatment with cotrimoxazole vs. vancomycin
for invasive MRSA infections. The primary efficacy outcome we will assess will be Improvement
or cure with or without antibiotic modifications, defined as: survival at 7 days post
randomization with resolution of fever (<38 for two consecutive days) and resolution of
hypotension (>90 systolic without need for vasopressor support); and physician's assessment
that the primary infection was improved or cured. The primary safety outcome will be
all-cause 30-day survival.
Phase:
Phase 3
Details
Lead Sponsor:
Rabin Medical Center
Treatments:
Methicillin Sulfamethoxazole Trimethoprim Trimethoprim, Sulfamethoxazole Drug Combination Vancomycin