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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00711854
Recruitment Status : Completed
First Posted : July 9, 2008
Last Update Posted : August 5, 2014
Information provided by (Responsible Party):
Stephen Harbarth, University Hospital, Geneva

Brief 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.

Condition or disease Intervention/treatment Phase
MRSA Infection Drug: trimethoprim-sulfamethoxazole (TMP-SMX) Drug: Linezolid Drug: Rifampicin Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : January 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA

Arm Intervention/treatment
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)

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

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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00711854

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

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
First Posted: July 9, 2008    Key Record Dates
Last Update Posted: August 5, 2014
Last Verified: August 2014

Keywords provided by Stephen Harbarth, University Hospital, Geneva:
Staphylococcal infection

Additional relevant MeSH terms:
Communicable Diseases
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Protein Synthesis Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antiprotozoal Agents