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
Information source: University Hospital, Geneva
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: MRSA Infection
Intervention: trimethoprim-sulfamethoxazole (TMP-SMX) (Drug); Linezolid (Drug); Rifampicin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: University Hospital, Geneva Official(s) and/or principal investigator(s): Stephan Harbarth, MD, MS, Principal Investigator, Affiliation: University Hospital, Geneva
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Bacteriological and clinical cure
Secondary outcome: Treatment costs
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Geneva University Hospitals, Geneva 1211, Switzerland
Additional Information
MRSA research center, Geneva University Hospitals and Medical School
Starting date: January 2009
Last updated: August 4, 2014
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