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

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

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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne

  lead OTHER

Principal Investigators

• Kasra AZARNOUSH, MD PhD · CHU SAINT-ETIENNE

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-29

Primary Completion

2025-03-04

Completion

2025-12-31

Countries

• France

Study Locations