Optimal treatment for MRSA throat carriers

A Randomized Placebo-controlled Double-blinded Trial of the Treatment of MRSA Throat Carriage With Either Standard Decolonization Therapy or Standard Decolonization Therapy Combined With Oral Clindamycin

This study is testing whether clindamycin can help people who still have MRSA in their throats after standard treatment, compared to a placebo.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hvidovre University Hospital (Academic / other)
• Locations: 1 site (Hvidovre)
• Trial ID: NCT04104178 on ClinicalTrials.gov

What this trial studies

This study investigates the best treatment methods for individuals who carry methicillin-resistant Staphylococcus aureus (MRSA) in their throats. It focuses on patients who have undergone a standard topical decolonization treatment but still show MRSA presence. Participants will be treated with either clindamycin or a placebo to evaluate the effectiveness of the treatment. The study aims to address the growing challenge of antibiotic resistance and improve outcomes for MRSA carriers.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are confirmed MRSA carriers in the throat after initial treatment.

Not a fit: Patients who are pregnant, have active infections, or are allergic to clindamycin will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective treatments for MRSA throat carriers, reducing the risk of infections and improving patient health.

How similar studies have performed: Other studies have explored treatments for MRSA, but this specific approach to throat carriers is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* MRSA carriage in the throat after first topical decolonization treatment (regardless of previous swab results)
* Has completed one standard topical decolonization treatment

Exclusion Criteria:

* Pregnant or lactating woman
* Sexually active women in the reproductive age that do not use approved contraceptives (appendix 4)
* Cannot read or speak Danish (the written participant information is in Danish)
* Skin infection or other active infections
* Activity in skin diseases such as eczema or psoriasis.
* MRSA isolate resistant to clindamycin (defined by inhibition zone size \< 22 mm using disk diffusion methodology) or resistant to mupirocin
* Allergy to clindamycin, chlorhexidine or mupirocin
* Taking medications that interact with clindamycin according to the medicine information leaflet.
* MRSA active antibiotic treatment within 7 days before inclusion in the study or during study period
* Followed by specialist due to liver disease
* Severe overweight (BMI \> 35) or weight \< 50 kg
* Indwelling percutaneous permanent devices such as intravenous catheters or urinary tract catheters
* Daily contact with pigs or minks (decolonization therapy is generally not offered, according to The National Board of Health)
* Nursing home resident or health care worker (they have a more frequent control swab regime)
* Not being capable of completing another treatment successfully
* MRSA positive household members younger than 2 years (MRSA positive children below 2 years of age and their household members are generally not offered decolonization treatment according to The National Board of Health)
* MRSA positive household members, where it is judged that further decolonization attempts are not indicated

Where this trial is running

Hvidovre

• Hvidovre Hospital — Hvidovre, Denmark (Recruiting)

Study contacts

• Principal investigator: Mona KA Holm, MD — Hvidovre University Hospital
• Study coordinator: Mona KA Holm, MD

Conditions MRSA; MRSA Colonization