MRSA Clinical Trial
— CLEANESTOfficial title:
MRSA Decolonization in Complicated Carriage - Cluster Randomized Trial
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.
Status | Recruiting |
Enrollment | 211 |
Est. completion date | April 1, 2024 |
Est. primary completion date | April 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | LUMC | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | success rate | success rate of MRSA decolonization | 3 consecutive negative cultures after treatment, with a minimum interval of 7 days. | |
Secondary | long term success rate | success rate of decolonization treatment after 1 year | 1 year |
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