A randomized, placebo-controlled, double-blinded trial of MRSA throat carriage treatment, with either standard decolonization alone or in combination with oral clindamycin

Abstract

Abstract Background Staphylococcus aureus is a frequent colonizer of the human skin and mucous membranes but can also cause a variety of serious infections. Antimicrobial resistance is an increasing worldwide challenge and is mainly driven by an overuse of antimicrobials. To avoid the spread of methicillin-resistant Staphylococcus aureus (MRSA) in Denmark, the Danish Health Authority recommends decolonization treatment of MRSA carriers and their household contacts. Standard decolonization treatment includes chlorhexidine body wash and mupirocin nasal ointment, especially throat carriage is difficult to treat. The broad-spectrum antibiotic, clindamycin, is often added to the decolonization treatment, but there is currently low scientific evidence for this treatment. Aim To investigate whether the addition of clindamycin to the standard decolonization treatment increases decolonization success in MRSA throat carriers. Methods A randomized, placebo-controlled, double-blinded trial, including patients ≥ 18 years, who tested MRSA positive in the throat after completing one standard decolonization treatment. All carriers included in the trial receive standard decolonization treatment and are randomized to treatment with either placebo or clindamycin capsules for 10 days. We plan to include 40 participants in each of the two treatment arms. Discussion Due to the lack of consistent scientific evidence of clindamycin’s effect in MRSA decolonization and the worldwide urgent need to reduce the use of antibiotics, we judged that a 30% increase in the decolonization success rate in carriers treated with clindamycin is appropriate to justify prescribing clindamycin as part of the decolonization treatment of asymptomatic MRSA carriers. Trial registration EudraCT number 2019-002631-29

Keywords

• Methicillin-resistant Staphylococcus aureus
• MRSA throat carriage
• Treatment failure
• MRSA decolonization
• MRSA eradication