Full Text View
Tabular View
No Study Results Posted
Related Studies
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 is currently recruiting participants.
Verified by University Hospital, Geneva, January 2009
First Received: July 3, 2008   Last Updated: January 16, 2009   History of Changes
Sponsors and Collaborators: University Hospital, Geneva
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: 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)

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment costs [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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
1: Experimental
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)
2: Active Comparator
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
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711854

Contacts
Contact: Stephan Harbarth, MD MS 41223723311 stephan.harbarth@hcuge.ch

Locations
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            
Sponsors and Collaborators
University Hospital, Geneva
Clinical Research Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by University Hospital, Geneva:
Staphylococcal infection

Study placed in the following topic categories:
Bacterial Infections
Anti-Infective Agents
Trimethoprim
Sulfamethoxazole
Folate
Trimethoprim-Sulfamethoxazole Combination
Anti-Infective Agents, Urinary
Folinic Acid
Folic Acid Antagonists
Vitamin B9
Folic Acid
Antimalarials
Staphylococcal Infections
Rifampin
Anti-Bacterial Agents
Gram-Positive Bacterial Infections
Methicillin
Antitubercular Agents
Linezolid

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 11, 2009