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

Last updated: January 9, 2025
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Overall Status: Active - Recruiting

Phase

1

Condition

Staphylococcal Infections

Treatment

blood samples after Single dose part

Mupirocin (500 mg)

nasal swab after Repeated dose part

Clinical Study ID

NCT06368856
20CH024
2020-006105-30
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subject affiliated or entitled to a social security plan

  • Subject having signed the consent to participate in the study

Exclusion

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.)

Study Design

Total Participants: 40
Treatment Group(s): 8
Primary Treatment: blood samples after Single dose part
Phase: 1
Study Start date:
February 29, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHU de SAINT-ETIENNE

    Saint-Étienne,
    France

    Active - Recruiting

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