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

NCT06368856 | Active Not Recruiting Phase 1

• 2 other identifiers: 20CH0242020-006105-30
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Staphylococcus Aureus Infection

Keywords

Staphylococcus Aureus; Mupirocin; Pharmacokinetic

Outcome Measures

Primary Outcomes (9)

• plasma concentrations of mupirocin

  mupirocin pharmacokinetics

  0 hours 30 after mupirocin application (Single dose part)

• plasma concentrations of mupirocin

  mupirocin pharmacokinetics

  1 hours after mupirocin application (Single dose part)

• plasma concentrations of mupirocin

  mupirocin pharmacokinetics

  2 hours after mupirocin application (Single dose part)

• intranasal concentrations of mupirocin

  mupirocin pharmacokinetics

  1 hours after mupirocin application (Single dose part)

• intranasal concentrations of mupirocin

  mupirocin pharmacokinetics

  2 hours after mupirocin application (Single dose part)

• intranasal concentrations of mupirocin

  mupirocin pharmacokinetics

  4 hours after mupirocin application (Single dose part)

• intranasal concentrations of mupirocin

  mupirocin pharmacokinetics

  6 hours after mupirocin application (Single dose part)

• intranasal concentrations of mupirocin

  mupirocin pharmacokinetics

  8 hours after mupirocin application (Single dose part)

• intranasal concentrations of mupirocin

  mupirocin pharmacokinetics

  12 hours after mupirocin application (Single dose part)

Secondary Outcomes (8)

• presence of Staphylococcus aureus

  Days: 5 after mupirocin application (Repeated dose part)

• presence of Staphylococcus aureus

  Days: 6 after mupirocin application (Repeated dose part)

• presence of Staphylococcus aureus

  Days: 30 after mupirocin application (Repeated dose part)

• presence of Staphylococcus aureus

  Days: 90 after mupirocin application (Repeated dose part)

• urinary concentrations of monic acid

  Days: 2 after mupirocin application (Repeated dose part)

Study Arms (6)

Single dose part : 50mg mupirocin

ACTIVE COMPARATOR

\- Single dose part = single dose of 50 mg mupirocin in each nostril

Drug: Mupirocin (50 mg); Biological: blood samples after Single dose part; Diagnostic Test: nasal swab after Single dose part; Other: Collection of urine after Single dose part

Single dose part : 500mg mupirocin

EXPERIMENTAL

Single dose part = single dose of 500 mg mupirocin in each nostril

Drug: Mupirocin (500 mg); Biological: blood samples after Single dose part; Diagnostic Test: nasal swab after Single dose part; Other: Collection of urine after Single dose part

Repeated dose part: Group 1 - 50 mg of mupirocin twice a day

EXPERIMENTAL

50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days

Drug: Mupirocin (50 mg); Diagnostic Test: nasal swab during Repeated dose part; Other: Collection of urine during Repeated dose part; Other: nasal swab after Repeated dose part

Repeated dose part: Group 2 50 mg of mupirocin 3 times a day

EXPERIMENTAL

50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days

Drug: Mupirocin (50 mg); Diagnostic Test: nasal swab during Repeated dose part; Other: Collection of urine during Repeated dose part; Other: nasal swab after Repeated dose part

Repeated dose part: Group 3 500 mg of mupirocin twice a day

EXPERIMENTAL

500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days

Drug: Mupirocin (500 mg); Diagnostic Test: nasal swab during Repeated dose part; Other: Collection of urine during Repeated dose part; Other: nasal swab after Repeated dose part

Repeated dose part: Group 4 500 mg of mupirocin 3 times a day

EXPERIMENTAL

500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days

Drug: Mupirocin (500 mg); Diagnostic Test: nasal swab during Repeated dose part; Other: Collection of urine during Repeated dose part; Other: nasal swab after Repeated dose part

Interventions

Mupirocin (50 mg) DRUG

50 mg de mupirocin

Also known as: Bactroban

Repeated dose part: Group 1 - 50 mg of mupirocin twice a day; Repeated dose part: Group 2 50 mg of mupirocin 3 times a day; Single dose part : 50mg mupirocin

Mupirocin (500 mg) DRUG

500 mg de mupirocin

Also known as: Bactroban

Repeated dose part: Group 3 500 mg of mupirocin twice a day; Repeated dose part: Group 4 500 mg of mupirocin 3 times a day; Single dose part : 500mg mupirocin

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

Single dose part : 500mg mupirocin; Single dose part : 50mg mupirocin

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

Also known as: intranasal concentrations

Single dose part : 500mg mupirocin; Single dose part : 50mg mupirocin

Collection of urine after Single dose part OTHER

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

Single dose part : 500mg mupirocin; Single dose part : 50mg mupirocin

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)

Repeated dose part: Group 1 - 50 mg of mupirocin twice a day; Repeated dose part: Group 2 50 mg of mupirocin 3 times a day; Repeated dose part: Group 3 500 mg of mupirocin twice a day; Repeated dose part: Group 4 500 mg of mupirocin 3 times a day

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)

Repeated dose part: Group 1 - 50 mg of mupirocin twice a day; Repeated dose part: Group 2 50 mg of mupirocin 3 times a day; Repeated dose part: Group 3 500 mg of mupirocin twice a day; Repeated dose part: Group 4 500 mg of mupirocin 3 times a day

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)

Repeated dose part: Group 1 - 50 mg of mupirocin twice a day; Repeated dose part: Group 2 50 mg of mupirocin 3 times a day; Repeated dose part: Group 3 500 mg of mupirocin twice a day; Repeated dose part: Group 4 500 mg of mupirocin 3 times a day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de SAINT-ETIENNE

Saint-Etienne, France

Location

MeSH Terms

Conditions

Staphylococcal Infections

Interventions

Mupirocin

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Epoxy Compounds; Ethers, Cyclic; Ethers; Organic Chemicals; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids

Study Officials

• Kasra AZARNOUSH, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, open-label pharmacokinetic study of mupirocin in 40 healthy subjects with 2 randomization : * first randomization - single dose part : 50mg or 500mg of mupirocin * wash-out: one month * second randomization - repeated doses part: 50mg mupirocin twice a day or 50 mg 3 times a day 500mg mupirocin twice a day or 500mg mupirocin 3 times a day

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 16, 2024
• Study Start: February 29, 2024
• Primary Completion: March 4, 2025
• Study Completion: December 1, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)