Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
211 participants
INTERVENTIONAL
2022-07-25
2028-05-01
Brief Summary
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Detailed Description
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Objective: To determine the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
Study design: Multicenter open-label cluster randomized controlled trial.
Study population: Adult (\>18 years) patients with complicated MRSA carriership, treated at one of the participating outpatient clinics. Sample size 211 patients.
Intervention: Group A: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. versus Group B: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. All orally, total duration 7 days.
Main study parameters/endpoints: The main study endpoint is the success rate of MRSA decolonization. Successful decolonization is defined as 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: MRSA decolonization treatment is already standard clinical practice in the Netherlands. There is no additional burden or risk associated with participation in the study. Both antibiotic regimens (in Group A and Group B) used in the study, are recommended as first-line therapy by the Dutch guideline for the treatment of MRSA carriage. The study is open label, so there is no additional risk of blinding. The number of outpatient visits and follow-up cultures are not different from daily clinical practice in the Netherlands. No invasive procedures will be performed for the purpose of this study.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A
doxycycline 200 mg q.d. - rifampicin 600mg b.i.d.
doxycycline 200 mg q.d. - rifampicin 600mg b.i.d.
Both first choice treatments in Dutch guideline for MRSA decolonization
B
trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.
trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.
Both first choice treatments in Dutch guideline for MRSA decolonization
Interventions
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doxycycline 200 mg q.d. - rifampicin 600mg b.i.d.
Both first choice treatments in Dutch guideline for MRSA decolonization
trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.
Both first choice treatments in Dutch guideline for MRSA decolonization
Eligibility Criteria
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Inclusion Criteria
* Complicated MRSA carriership. Complicated carriership is defined as having one of the following features: (i) the presence of MRSA located at another site than the nose, (ii) an active infection with MRSA, (iii) in vitro resistance for mupirocin, (iv) active skin lesions, (v) foreign material that connects an internal body site with the outside (e.g., urine catheter, external fixation material), (vi) previously failure of decolonization treatment.
In case of none of the previously mentioned features, this is considered uncomplicated carriership.
\- The ability to provide informed consent for the use of their data.
Exclusion Criteria
* Failure of previous decolonization attempt of complicated MRSA carriage
* Allergy or other contra-indication to either doxycycline, rifampicin or trimethoprim (these patients will participate in the observational arm)
* Previous participation in this study (every patient can only participate once)
* Pregnancy
18 Years
ALL
No
Sponsors
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Leiden University Medical Center
OTHER
Responsible Party
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acwestgeest
Principal investigator
Principal Investigators
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Merel Lambregts, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Leiden University Medical Center
Locations
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LUMC
Leiden, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Merel Lambregts
Role: primary
Other Identifiers
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NL79720.058.21
Identifier Type: -
Identifier Source: org_study_id
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