Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study
NCT ID: NCT06368856
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
40 participants
INTERVENTIONAL
2024-02-29
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
* 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
OTHER
NONE
Study Groups
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Single dose part : 50mg mupirocin
\- Single dose part = single dose of 50 mg mupirocin in each nostril
Mupirocin (50 mg)
50 mg de mupirocin
blood samples after Single dose part
3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00
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
Collection of urine after Single dose part
Collection of urine during 12 hours after the application of mupirocin (Single dose part)
Single dose part : 500mg mupirocin
Single dose part = single dose of 500 mg mupirocin in each nostril
Mupirocin (500 mg)
500 mg de mupirocin
blood samples after Single dose part
3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00
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
Collection of urine after Single dose part
Collection of urine during 12 hours after the application of mupirocin (Single dose part)
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day
50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Mupirocin (50 mg)
50 mg de mupirocin
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)
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)
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)
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day
50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
Mupirocin (50 mg)
50 mg de mupirocin
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)
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)
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)
Repeated dose part: Group 3 500 mg of mupirocin twice a day
500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
Mupirocin (500 mg)
500 mg de mupirocin
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)
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)
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)
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day
500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
Mupirocin (500 mg)
500 mg de mupirocin
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)
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)
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)
Interventions
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Mupirocin (50 mg)
50 mg de mupirocin
Mupirocin (500 mg)
500 mg de mupirocin
blood samples after Single dose part
3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00
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
Collection of urine after Single dose part
Collection of urine during 12 hours after the application of mupirocin (Single dose part)
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)
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)
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject having signed the consent to participate in the study
Exclusion Criteria
* 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.)
18 Years
ALL
Yes
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Kasra AZARNOUSH, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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CHU de SAINT-ETIENNE
Saint-Etienne, , France
Countries
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Other Identifiers
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2020-006105-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20CH024
Identifier Type: -
Identifier Source: org_study_id
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