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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

This study has been completed.
Information provided by (Responsible Party):
Stephen Harbarth, University Hospital, Geneva Identifier:
First received: July 3, 2008
Last updated: August 4, 2014
Last verified: August 2014
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
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)

Resource links provided by NLM:

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Bacteriological and clinical cure [ Time Frame: 6 weeks ]

Secondary Outcome Measures:
  • Treatment costs [ Time Frame: 6 weeks ]

Enrollment: 150
Study Start Date: January 2009
Study Completion Date: February 2014
Primary Completion Date: December 2013 (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
Drug: Linezolid
Linezolid (600 mg IV or PO twice daily)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 18 years
  2. Patients with clinical signs and symptoms of MRSA-related infection
  3. Culture of MRSA (predominant microorganism in culture) susceptible to all of the following:

    • TMP-SMX
    • rifampicin
    • linezolid
  4. Patient must give written informed consent to participate in the study.

Exclusion Criteria:

  1. Women who are pregnant or nursing
  2. Women who refuse to substitute oral contraception during treatment
  3. Known or suspected hypersensitivity to linezolid, TMP-SMX or rifampicin
  4. Clinical or laboratory evidence of significant impairment of hepatic function, as demonstrated by any of the following criteria:

    • Bilirubin > 3 x upper limit of normal range
    • AST or ALT > 5 x upper limit of normal range
    • Acute hepatitis or proven liver cirrhosis by liver histology
  5. Treatment with other antimicrobials with activity against MRSA for > 72 hours prior to study inclusion
  6. Patients with a high probability of death within the week following study entry
  7. Patients who, in the opinion of the investigator, cannot be relied upon for post-therapy follow-up
  8. Patients requiring alternative antibiotic therapy with anti-MRSA activity. However, if another antibiotic treatment without antistaphylococcal activity is necessary, the patient is acceptable for randomization. In that sense, the use of aztreonam (against Gram negative microorganisms) or metronidazole (against anaerobes) is allowed
  9. Hemodialyzed patients
  10. History of pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism, uncontrolled hypertension, or patients receiving serotonin uptake inhibitors
  11. Severe thrombocytopenia (< 50.000 platelets)
  12. Left-sided endocarditis with a poor prognosis (patients aged over 50; cerebral embolism)
  13. Chronic osteomyelitis without surgical debridement; superinfected indwelling foreign body, deliberately kept in place
  14. Patients with severe sepsis or septic shock due to MRSA bacteremia
  15. Patients who receive any of the following drugs, which cannot be substituted or temporarily withdrawn: adrenergic and serotonergic agents, tramadol, pethidine, duloxetine, venlafaxine, milnacipran, sibutramine, chlorpheniramine, brompheniramine, cyproheptadine, citalopram, and paroxetine.
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Please refer to this study by its identifier: NCT00711854

Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Principal Investigator: Stephan Harbarth, MD, MS University Hospital, Geneva
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stephen Harbarth, Professor, University Hospital, Geneva Identifier: NCT00711854     History of Changes
Other Study ID Numbers: 08-059
Study First Received: July 3, 2008
Last Updated: August 4, 2014

Keywords provided by University Hospital, Geneva:
Staphylococcal infection

Additional relevant MeSH terms:
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Trimethoprim, Sulfamethoxazole Drug Combination
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Cytochrome P-450 CYP2C8 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antibiotics, Antitubercular
Antitubercular Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers processed this record on April 21, 2017