MRSA InfectionPhase 4NCT00711854
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
A Phase 4 study testing trimethoprim-sulfamethoxazole (TMP-SMX), Linezolid and Rifampicin in people with MRSA Infection, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA Infection
- What is being tested?
- trimethoprim-sulfamethoxazole (TMP-SMX), Linezolid and Rifampicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Feb 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patients with clinical signs and symptoms of MRSA-related infection
- Culture of MRSA (predominant microorganism in culture) susceptible to all of the following:
- TMP-SMX
- rifampicin
- linezolid
- Patient must give written informed consent to participate in the study.
Who cannot join
- Women who are pregnant or nursing
- Women who refuse to substitute oral contraception during treatment
- Known or suspected hypersensitivity to linezolid, TMP-SMX or rifampicin
- 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
Show all 18Show fewer
- Acute hepatitis or proven liver cirrhosis by liver histology
- Treatment with other antimicrobials with activity against MRSA for > 72 hours prior to study inclusion
- Patients with a high probability of death within the week following study entry
- Patients who, in the opinion of the investigator, cannot be relied upon for post-therapy follow-up
- 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
- Hemodialyzed patients
- History of pheochromocytoma, carcinoid syndrome, untreated hyperthyroidism, uncontrolled hypertension, or patients receiving serotonin uptake inhibitors
- Severe thrombocytopenia (< 50.000 platelets)
- Left-sided endocarditis with a poor prognosis (patients aged over 50; cerebral embolism)
- Chronic osteomyelitis without surgical debridement; superinfected indwelling foreign body, deliberately kept in place
- Patients with severe sepsis or septic shock due to MRSA bacteremia
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
- Conditions
- MRSA Infection
- Being tested
- trimethoprim-sulfamethoxazole (TMP-SMX), Linezolid, Rifampicin
- Keywords
- Staphylococcal infection
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trimethoprim-sulfamethoxazole (TMP-SMX)Drug
TMP-SMX (160 mg TMP/ 800 mg SMX IV or PO 3x daily)
LinezolidDrug
Linezolid (600 mg IV or PO twice daily)
RifampicinDrug
Rifampicin (600 mg IV or PO once daily)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | trimethoprim-sulfamethoxazole (TMP-SMX) plus rifampicin Receives: Drug: trimethoprim-sulfamethoxazole (TMP-SMX); Drug: Rifampicin |
| 2 | Active comparator | Linezolid Receives: Drug: Linezolid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriological and clinical cure
Measured: 6 weeks
Secondary outcomes (1)
Treatment costs
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MRSA InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Harbarth, University Hospital, Geneva
- Investigators
- Stephan Harbarth, MD, MS, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711854
- Sponsor's protocol ID
- 08-059
- Status last verified
- Aug 2014
- First submitted
- 3 Jul 2008
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Harbarth S, von Dach E, Pagani L, Macedo-Vinas M, Huttner B, Olearo F, Emonet S, Uckay I. Randomized non-inferiority trial to compare trimethoprim/sulfamethoxazole plus rifampicin versus linezolid for the treatment of MRSA infection. J Antimicrob Chemother. 2015 Jan;70(1):264-72. doi: 10.1093/jac/dku352. Epub 2014 Sep 10.
PubMed 25209610
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00711854
- Acronym / sponsor ID
- 08-059
- Conditions
- MRSA Infection
- Keywords
- Staphylococcal infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: trimethoprim-sulfamethoxazole (TMP-SMX), Drug: Rifampicintrimethoprim-sulfamethoxazole (TMP-SMX) plus rifampicin |
| 2 | Active comparator | Drug: LinezolidLinezolid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Patients with clinical signs and symptoms of MRSA-related infection
- Culture of MRSA (predominant microorganism in culture) susceptible to all of the following:
- Patient must give written informed consent to participate in the study.
Key exclusion criteria (18 listed)
- Women who are pregnant or nursing
- Women who refuse to substitute oral contraception during treatment
- Known or suspected hypersensitivity to linezolid, TMP-SMX or rifampicin
- Clinical or laboratory evidence of significant impairment of hepatic function, as demonstrated by any of the following criteria:
- Treatment with other antimicrobials with activity against MRSA for > 72 hours prior to study inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trimethoprim-sulfamethoxazole (TMP-SMX)TMP-SMX (160 mg TMP/ 800 mg SMX IV or PO 3x daily) | Drug | 1 |
| LinezolidLinezolid (600 mg IV or PO twice daily) | Drug | 2 |
| RifampicinRifampicin (600 mg IV or PO once daily) | Drug | 1 |
Primary outcome
Bacteriological and clinical cure
Time frame: 6 weeks
1 secondary outcome
Treatment costs
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Derived from this study: PubMed 25209610Harbarth S, von Dach E, Pagani L, Macedo-Vinas M, Huttner B, Olearo F, Emonet S, Uckay I. Randomized non-inferiority trial to compare trimethoprim/sulfamethoxazole plus rifampicin versus linezolid for the treatment of MRSA infection. J Antimicrob Chemother. 2015 Jan;70(1):264-72. doi: 10.1093/jac/dku352. Epub 2014 Sep 10.
- MRSA research center, Geneva University Hospitals and Medical SchoolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan Harbarth, MD, MS principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing trimethoprim-sulfamethoxazole (TMP-SMX), Linezolid and Rifampicin in people with MRSA Infection, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteriological and clinical cure (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00711854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.