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| Sponsor: | University Hospital, Geneva |
|---|---|
| Collaborator: |
Clinical Research Center |
| Information provided by: | University Hospital, Geneva |
| ClinicalTrials.gov Identifier: | NCT00711854 |
Purpose
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 |
|---|---|---|
|
MRSA Infection |
Drug: trimethoprim-sulfamethoxazole (TMP-SMX) Drug: Linezolid Drug: Rifampicin |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
trimethoprim-sulfamethoxazole (TMP-SMX) plus rifampicin
|
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)
|
|
Active Comparator: 2
Linezolid
|
Drug: Linezolid
Linezolid (600 mg IV or PO twice daily)
|
Eligibility| 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:
Contacts and Locations| 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 | |
| Principal Investigator: | Stephan Harbarth, MD, MS | Geneva University Hospitals |
More Information
| Responsible Party: | Dr Stephan Harbarth, Geneva University Hospitals |
| ClinicalTrials.gov Identifier: | NCT00711854 History of Changes |
| Other Study ID Numbers: | 08-059 |
| Study First Received: | July 3, 2008 |
| Last Updated: | November 16, 2009 |
| Health Authority: | Switzerland: Swissmedic |
|
Staphylococcal infection |
|
Staphylococcal Infections Gram-Positive Bacterial Infections Bacterial Infections Methicillin Rifampin Linezolid Sulfamethoxazole Trimethoprim Trimethoprim-Sulfamethoxazole Combination Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
Antibiotics, Antitubercular Antitubercular Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Folic Acid Antagonists Protein Synthesis Inhibitors |