Clinical Trial

Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study

Study acronym: MUPIPHARM
Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
Summary
Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively. As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule. Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril. Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application. It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-04-11; most recent amendment 2025-07-02.
Status change: Recruiting → Active, Not Recruiting 2025-07-02
Trial Details
NCT Number NCT06368856
Lead Sponsor Centre Hospitalier Universitaire de Saint Etienne
Conditions Healthy, Staphylococcus Aureus Infection
Enrollment 40 participants
Start Date 2024-02-29
Primary Completion 2025-03-04 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-03