CHU de SAINT-ETIENNE
Saint-Etienne, France
NCT Number: NCT06368856
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Saint-Etienne, France
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 mg de mupirocin
Other names: Bactroban
500 mg de mupirocin
Other names: 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
Other names: 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)
Time frame: 0 hours 30 after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 1 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 2 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 1 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 2 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 4 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 6 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 8 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: 12 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
Time frame: Days: 5 after mupirocin application (Repeated dose part)
Measured by nasal swab results
Time frame: Days: 6 after mupirocin application (Repeated dose part)
Measured by nasal swab results
Time frame: Days: 30 after mupirocin application (Repeated dose part)
Measured by nasal swab results
Time frame: Days: 90 after mupirocin application (Repeated dose part)
Measured by nasal swab results
Time frame: Days: 2 after mupirocin application (Repeated dose part)
Analysis collection urine.
Time frame: Days: 3 after mupirocin application (Repeated dose part)
Analysis collection urine.
Time frame: Days: 4 after mupirocin application (Repeated dose part)
Analysis collection urine.
Time frame: Days: 5 after mupirocin application (Repeated dose part)
Analysis collection urine.
Centre Hospitalier Universitaire de Saint Etienne
Other
Acronym: MUPIPHARM
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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