drugset / Trial / NCT00711854

Randomized Clinical Trial to Compare a Regimen of Trimethoprim-sulfamethoxazole Plus Rifampicin With a Regimen of Linezolid in the Treatment of Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection

NCT00711854 ↗

Phase 4 Completed 150 enrolled University Hospital, Geneva
RandomizedParallel-groupOpen-labelTreatment

Summary

MRSA infections often require systemic antibiotic therapy and represent an important healthcare burden. Currently available treatment options are either only available in parenteral form (vancomycin) or expensive (linezolid). Thus, there is an urgent, unmet need to better investigate in-expensive but highly active alternatives to currently recommended standard treatment options. The purpose of the proposed study is to test the hypothesis that a combination of TMP-SMX and rifampicin is not inferior to linezolid for treatment of MRSA infections.

Timeline

Start
2009-01
Primary completion
2013-12
Completion
2014-02

Outcome

Met primary endpoint

paper 56/75 (74.7%) in the linezolid group and 59/75 (78.7%) in the trimethoprim/sulfamethoxazole and rifampicin group experienced clinical success (risk difference 4%, 95% CI -9.7% to 17.6%). PMID 25209610 ↗

paper Compared with linezolid, trimethoprim/sulfamethoxazole and rifampicin seems to be non-inferior in the treatment of MRSA infection. PMID 25209610 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Linezolid Other / unclassified 600 mg Intravenous
Subject Rifampicin Small molecule 600 mg Intravenous
Subject trimethoprim-sulfamethoxazole Unknown 160 mg Intravenous
Subject trimethoprim-sulfamethoxazole Unknown 800 mg Intravenous