A Phase 1 interventional study of Mupirocin (50 mg) and Mupirocin (500 mg) in Healthy and Staphylococcus Aureus Infection, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 1, Interventional, and Other
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.
273 studies on the registry are indexed under Staphylococcal Infections; 29 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 177 interventional studies indexed under Staphylococcal Infections.
Browse Staphylococcal Infections studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
\- 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 = 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
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
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
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
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
50 mg de mupirocin
Also known as: Bactroban
500 mg de mupirocin
Also known as: Bactroban
3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00
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
Collection of urine during 12 hours after the application of mupirocin (Single 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)
5 collections of urine during Repeated dose part: 2, 3, 4, 5 et 6 days after the first application of mupirocin (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)
plasma concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 0 hours 30 after mupirocin application (Single dose part)
plasma concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 1 hours after mupirocin application (Single dose part)
plasma concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 2 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 1 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 2 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 4 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 6 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 8 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Time frame: 12 hours after mupirocin application (Single dose part)
presence of Staphylococcus aureus
Measured by nasal swab results
Time frame: Days: 5 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Measured by nasal swab results
Time frame: Days: 6 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Measured by nasal swab results
Time frame: Days: 30 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Measured by nasal swab results
Time frame: Days: 90 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Time frame: Days: 2 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Time frame: Days: 3 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Time frame: Days: 4 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Time frame: Days: 5 after mupirocin application (Repeated dose part)
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne