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Sponsors and Collaborators: |
University Hospital, Geneva Clinical Research Center |
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Information provided by: | University Hospital, Geneva |
ClinicalTrials.gov Identifier: | NCT00711854 |
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.
Condition | Intervention | Phase |
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MRSA Infection |
Drug: trimethoprim-sulfamethoxazole (TMP-SMX) Drug: Linezolid Drug: Rifampicin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Randomized Clinical Trial to Compare a Regimen of Trimethoprim-Sulfamethoxazole (TMP-SMX) Plus Rifampicin With a Regimen of Linezolid in the Treatment of Infections Caused by Methicillin-Resistant Staphylococcus Aureus (MRSA) |
Estimated Enrollment: | 180 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
trimethoprim-sulfamethoxazole (TMP-SMX) plus rifampicin
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Drug: trimethoprim-sulfamethoxazole (TMP-SMX)
TMP-SMX (160 mg TMP/ 800 mg SMX IV or PO 3x daily)
Drug: Rifampicin
Rifampicin (600 mg IV or PO once daily)
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2: Active Comparator
Linezolid
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Drug: Linezolid
Linezolid (600 mg IV or PO twice daily)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Culture of MRSA (predominant microorganism in culture) susceptible to all of the following:
Exclusion Criteria:
Clinical or laboratory evidence of significant impairment of hepatic function, as demonstrated by any of the following criteria:
Contact: Stephan Harbarth, MD MS | 41223723311 | stephan.harbarth@hcuge.ch |
Switzerland | |
Geneva University Hospitals | Recruiting |
Geneva, Switzerland, 1211 | |
Contact: Stephan Harbarth, MD MS 41223723357 stephan.harbarth@hcuge.ch | |
Contact: Alexander Mischnik, MD 41223723311 amischnik@gmx.net | |
Principal Investigator: Stephan Harbarth, MD MS |
Responsible Party: | Geneva University Hospitals ( Dr Stephan Harbarth ) |
Study ID Numbers: | 08-059 |
Study First Received: | July 3, 2008 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00711854 History of Changes |
Health Authority: | Switzerland: Swissmedic |
Staphylococcal infection |
Bacterial Infections Trimethoprim Sulfamethoxazole Trimethoprim-Sulfamethoxazole Combination Anti-Infective Agents, Urinary Folic Acid Antagonists Folic Acid Staphylococcal Infections |
Rifampin Anti-Bacterial Agents Antimalarials Gram-Positive Bacterial Infections Methicillin Antitubercular Agents Linezolid |
Bacterial Infections Anti-Infective Agents Communicable Diseases Trimethoprim Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Trimethoprim-Sulfamethoxazole Combination Infection Renal Agents Anti-Bacterial Agents Rifampin Antimalarials Antiparasitic Agents Gram-Positive Bacterial Infections |
Methicillin Therapeutic Uses Linezolid Nucleic Acid Synthesis Inhibitors Sulfamethoxazole Enzyme Inhibitors Anti-Infective Agents, Urinary Folic Acid Antagonists Pharmacologic Actions Antibiotics, Antitubercular Protein Synthesis Inhibitors Staphylococcal Infections Antitubercular Agents Leprostatic Agents |