protocolSection identificationModule nctId: NCT06368856, orgStudyIdInfo id: 20CH024, secondaryIdInfos id: 2020-006105-30, type: EUDRACT_NUMBER, briefTitle: Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study, acronym: MUPIPHARM, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Centre Hospitalier Universitaire de Saint Etienne, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Healthy, conditions: Staphylococcus Aureus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: 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, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Mupirocin (50 mg), interventions name: Mupirocin (500 mg), interventions name: blood samples after Single dose part, interventions name: nasal swab after Single dose part, interventions name: Collection of urine after Single dose part, interventions name: nasal swab during Repeated dose part, interventions name: Collection of urine during Repeated dose part, interventions name: nasal swab after Repeated dose part, outcomesModule primaryOutcomes measure: plasma concentrations of mupirocin, primaryOutcomes measure: plasma concentrations of mupirocin, primaryOutcomes measure: plasma concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, primaryOutcomes measure: intranasal concentrations of mupirocin, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: presence of Staphylococcus aureus, secondaryOutcomes measure: urinary concentrations of monic acid, secondaryOutcomes measure: urinary concentrations of monic acid, secondaryOutcomes measure: urinary concentrations of monic acid, secondaryOutcomes measure: urinary concentrations of monic acid, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de SAINT-ETIENNE, status: RECRUITING, city: Saint-Étienne, country: France, contacts name: Kasra AZARNOUSH, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Elisabeth BOTELHO-NEVERS, MD PhD, role: SUB_INVESTIGATOR, contacts name: Anne CARRICAJO, MD, role: SUB_INVESTIGATOR, contacts name: Philippe BERTHELOT, MD PhD, role: SUB_INVESTIGATOR, geoPoint lat: 45.43389, lon: 4.39, hasResults: False