Comparing two antibiotic combinations for treating complicated MRSA carriage
MRSA Decolonization in Complicated Carriage - Cluster Randomized Trial
NA · Leiden University Medical Center · NCT05268120
This study is testing whether a combination of doxycycline and rifampicin works better than trimethoprim and rifampicin to help adults get rid of complicated MRSA infections.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 211 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 1 site (Leiden) |
| Trial ID | NCT05268120 on ClinicalTrials.gov |
What this trial studies
This multicenter open-label cluster randomized controlled trial aims to determine whether doxycycline-rifampicin is more effective than trimethoprim-rifampicin for decolonizing patients with complicated MRSA carriage. The study will involve adult patients who meet specific criteria for complicated MRSA carriage and will compare the success rates of the two antibiotic regimens over a 7-day treatment period. The trial is designed to provide robust evidence to guide treatment recommendations for MRSA decolonization.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with complicated MRSA carriage, characterized by specific clinical features.
Not a fit: Patients with uncomplicated MRSA carriage or those with contraindications to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with complicated MRSA carriage, reducing infection rates and transmission.
How similar studies have performed: Previous studies have indicated that doxycycline-rifampicin may have a higher success rate for MRSA decolonization, but this study is necessary to confirm these findings through a randomized controlled approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Leiden
- LUMC — Leiden, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Merel Lambregts, MD PhD — Leiden University Medical Center
- Study coordinator: Annette Westgeest, MD
- Email: a.c.westgeest@lumc.nl
- Phone: +3171 5262613
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: MRSA