NCT06368856

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy
• Staphylococcus Aureus Infection

Interventions

Type	Name	Description
DRUG	Mupirocin (50 mg)	50 mg de mupirocin
DRUG	Mupirocin (500 mg)	500 mg de mupirocin
BIOLOGICAL	blood samples after Single dose part	3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00
DIAGNOSTIC_TEST	nasal swab after Single dose part	7 nasal swab for the detection of S. aureus (type Swab) will be performed after application of mupirocin (single dose part): 00h00, 1h00, 02h00, 04h00, 06h00, 08h00, 12h00
OTHER	Collection of urine after Single dose part	Collection of urine during 12 hours after the application of mupirocin (Single dose part)
DIAGNOSTIC_TEST	nasal swab during Repeated dose part	5 nasal swab for the detection of S. aureus (type Swab) will be performed during administration of mupirocin (Repeated dose part): 2, 3, 4, 5 et 6 days after the first application of mupirocin (Repeated dose part)
OTHER	Collection of urine during Repeated dose part	5 collections of urine during Repeated dose part: 2, 3, 4, 5 et 6 days after the first application of mupirocin (Repeated dose part)
OTHER	nasal swab after Repeated dose part	2 nasal swab for the detection of S. aureus (type Swab) will be performed: 1, 3 months after the first application of mupirocin (Repeated dose part)

Timeline

• Start date: 2024-02-29
• Primary completion: 2025-03-04
• Completion: 2025-12-01
• First posted: 2024-04-16
• Last updated: 2025-07-03

Locations

1 site across 1 country: France