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NCT Number: NCT06368856

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU de SAINT-ETIENNE

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.)

Treatment and study plan

Mupirocin (50 mg)

Drug

50 mg de mupirocin

Other names: Bactroban

Mupirocin (500 mg)

Drug

500 mg de mupirocin

Other names: Bactroban

blood samples after Single dose part

Biological

3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00

nasal swab after Single dose part

Diagnostic Test

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 names: intranasal concentrations

Collection of urine after Single dose part

Other

Collection of urine during 12 hours after the application of mupirocin (Single dose part)

nasal swab during Repeated dose part

Diagnostic Test

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)

Collection of urine during Repeated dose part

Other

5 collections of urine during Repeated dose part: 2, 3, 4, 5 et 6 days after the first application of mupirocin (Repeated dose part)

nasal swab after Repeated dose part

Other

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)

Primary outcomes

  1. plasma concentrations of mupirocin

    Time frame: 0 hours 30 after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  2. plasma concentrations of mupirocin

    Time frame: 1 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  3. plasma concentrations of mupirocin

    Time frame: 2 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  4. intranasal concentrations of mupirocin

    Time frame: 1 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  5. intranasal concentrations of mupirocin

    Time frame: 2 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  6. intranasal concentrations of mupirocin

    Time frame: 4 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  7. intranasal concentrations of mupirocin

    Time frame: 6 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  8. intranasal concentrations of mupirocin

    Time frame: 8 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

  9. intranasal concentrations of mupirocin

    Time frame: 12 hours after mupirocin application (Single dose part)

    mupirocin pharmacokinetics

Secondary outcomes

  1. presence of Staphylococcus aureus

    Time frame: Days: 5 after mupirocin application (Repeated dose part)

    Measured by nasal swab results

  2. presence of Staphylococcus aureus

    Time frame: Days: 6 after mupirocin application (Repeated dose part)

    Measured by nasal swab results

  3. presence of Staphylococcus aureus

    Time frame: Days: 30 after mupirocin application (Repeated dose part)

    Measured by nasal swab results

  4. presence of Staphylococcus aureus

    Time frame: Days: 90 after mupirocin application (Repeated dose part)

    Measured by nasal swab results

  5. urinary concentrations of monic acid

    Time frame: Days: 2 after mupirocin application (Repeated dose part)

    Analysis collection urine.

  6. urinary concentrations of monic acid

    Time frame: Days: 3 after mupirocin application (Repeated dose part)

    Analysis collection urine.

  7. urinary concentrations of monic acid

    Time frame: Days: 4 after mupirocin application (Repeated dose part)

    Analysis collection urine.

  8. urinary concentrations of monic acid

    Time frame: Days: 5 after mupirocin application (Repeated dose part)

    Analysis collection urine.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Acronym: MUPIPHARM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 16, 2024
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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