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

Phase 1

Recruiting

• Conditions: Healthy; Staphylococcus Aureus Infection
• Interventions: Drug: Mupirocin (500 mg); Drug: Mupirocin (50 mg); Biological: blood samples after Single dose part; Diagnostic Test: nasal swab during Repeated dose part; Diagnostic Test: nasal swab after Single dose part; Other: Collection of urine during Repeated dose part; Other: Collection of urine after Single dose part; Other: nasal swab after Repeated dose part

• Registration Number: NCT06368856
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-29
• Status Verified: 2024-04
• Study First Submitted: 2024-04-08
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Subject affiliated or entitled to a social security plan
• Subject having signed the consent to participate in the study

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Exclusion Criteria

• Pregnancy in progress
• Acute or chronic rhinorrhea
• Allergy to mupirocin calcium or excipients
• Any medication taken during the week preceding the beginning of the study
• Notable medical history (cardiovascular, pulmonary, neurological pathology, etc.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day	Mupirocin (500 mg)	500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
Repeated dose part: Group 3 500 mg of mupirocin twice a day	Mupirocin (500 mg)	500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Single dose part : 500mg mupirocin	Mupirocin (500 mg)	Single dose part = single dose of 500 mg mupirocin in each nostril
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day	Mupirocin (50 mg)	50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day	Mupirocin (50 mg)	50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
Single dose part : 50mg mupirocin	blood samples after Single dose part	- Single dose part = single dose of 50 mg mupirocin in each nostril
Single dose part : 50mg mupirocin	nasal swab after Single dose part	- Single dose part = single dose of 50 mg mupirocin in each nostril
Single dose part : 50mg mupirocin	Collection of urine after Single dose part	- Single dose part = single dose of 50 mg mupirocin in each nostril
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day	Collection of urine during Repeated dose part	50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day	nasal swab after Repeated dose part	50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
Repeated dose part: Group 3 500 mg of mupirocin twice a day	Collection of urine during Repeated dose part	500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Single dose part : 50mg mupirocin	Mupirocin (50 mg)	- Single dose part = single dose of 50 mg mupirocin in each nostril
Single dose part : 500mg mupirocin	blood samples after Single dose part	Single dose part = single dose of 500 mg mupirocin in each nostril
Single dose part : 500mg mupirocin	nasal swab after Single dose part	Single dose part = single dose of 500 mg mupirocin in each nostril
Single dose part : 500mg mupirocin	Collection of urine after Single dose part	Single dose part = single dose of 500 mg mupirocin in each nostril
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day	nasal swab after Repeated dose part	50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day	nasal swab during Repeated dose part	50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day	Collection of urine during Repeated dose part	50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
Repeated dose part: Group 3 500 mg of mupirocin twice a day	nasal swab during Repeated dose part	500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day	nasal swab during Repeated dose part	50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day	nasal swab during Repeated dose part	500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
Repeated dose part: Group 3 500 mg of mupirocin twice a day	nasal swab after Repeated dose part	500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day	Collection of urine during Repeated dose part	500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day	nasal swab after Repeated dose part	500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days

Primary Outcome Measures

Name	Time	Method
plasma concentrations of mupirocin	2 hours after mupirocin application (Single dose part)	mupirocin pharmacokinetics
intranasal concentrations of mupirocin	12 hours after mupirocin application (Single dose part)	mupirocin pharmacokinetics

Secondary Outcome Measures

Name	Time	Method
urinary concentrations of monic acid	Days: 5 after mupirocin application (Repeated dose part)	Analysis collection urine.
presence of Staphylococcus aureus	Days: 90 after mupirocin application (Repeated dose part)	Measured by nasal swab results

Trial Locations

Locations (1)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-Étienne, France