MRSA Decolonization in Complicated Carriage
CLEANEST
1 other identifier
interventional
211
1 country
1
Brief Summary
Multicenter open-label cluster randomized controlled trial determining the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2022
CompletedFirst Posted
Study publicly available on registry
March 7, 2022
CompletedStudy Start
First participant enrolled
July 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
March 6, 2025
October 1, 2024
5.8 years
February 24, 2022
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
success rate
success rate of MRSA decolonization
3 consecutive negative cultures after treatment, with a minimum interval of 7 days.
Secondary Outcomes (1)
long term success rate
1 year
Study Arms (2)
A
ACTIVE COMPARATORdoxycycline 200 mg q.d. - rifampicin 600mg b.i.d.
B
ACTIVE COMPARATORtrimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.
Interventions
Both first choice treatments in Dutch guideline for MRSA decolonization
Both first choice treatments in Dutch guideline for MRSA decolonization
Eligibility Criteria
You may qualify if:
- Age ≥18 years
- 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.
You may not qualify if:
- \- Presence of any iv-access, urinary catheters or drains (because of high risk of treatment failure)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LUMC
Leiden, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Merel Lambregts, MD PhD
Leiden University Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 24, 2022
First Posted
March 7, 2022
Study Start
July 25, 2022
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
March 6, 2025
Record last verified: 2024-10