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

Healthy Clinical Trial

— MUPIPHARM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368856
• Other study ID #: 20CH024
• Secondary ID: 2020-006105-30
• Status: Recruiting
• Phase: Phase 1
• Start date: February 29, 2024
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Kasra AZARNOUSH, MD PhD
• Phone: (0)477829446
• Email: Kasra.Azarnoush[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject affiliated or entitled to a social security plan

• Subject having signed the consent to participate in the study

Exclusion Criteria:

• 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.)

Related Conditions & MeSH terms

• Healthy
• Staphylococcal Infections
• Staphylococcus Aureus Infection

Intervention

Drug:
• Mupirocin (50 mg)
50 mg de mupirocin
• Mupirocin (500 mg)
500 mg de mupirocin

Biological:
• blood samples after Single dose part
3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00

Diagnostic Test:
• 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

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

Diagnostic Test:
• 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)

Other:
• 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)

Locations

Country	Name	City	State
France	CHU de SAINT-ETIENNE	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma concentrations of mupirocin	mupirocin pharmacokinetics	0 hours 30 after mupirocin application (Single dose part)
Primary	plasma concentrations of mupirocin	mupirocin pharmacokinetics	1 hours after mupirocin application (Single dose part)
Primary	plasma concentrations of mupirocin	mupirocin pharmacokinetics	2 hours after mupirocin application (Single dose part)
Primary	intranasal concentrations of mupirocin	mupirocin pharmacokinetics	1 hours after mupirocin application (Single dose part)
Primary	intranasal concentrations of mupirocin	mupirocin pharmacokinetics	2 hours after mupirocin application (Single dose part)
Primary	intranasal concentrations of mupirocin	mupirocin pharmacokinetics	4 hours after mupirocin application (Single dose part)
Primary	intranasal concentrations of mupirocin	mupirocin pharmacokinetics	6 hours after mupirocin application (Single dose part)
Primary	intranasal concentrations of mupirocin	mupirocin pharmacokinetics	8 hours after mupirocin application (Single dose part)
Primary	intranasal concentrations of mupirocin	mupirocin pharmacokinetics	12 hours after mupirocin application (Single dose part)
Secondary	presence of Staphylococcus aureus	Measured by nasal swab results	Days: 5 after mupirocin application (Repeated dose part)
Secondary	presence of Staphylococcus aureus	Measured by nasal swab results	Days: 6 after mupirocin application (Repeated dose part)
Secondary	presence of Staphylococcus aureus	Measured by nasal swab results	Days: 30 after mupirocin application (Repeated dose part)
Secondary	presence of Staphylococcus aureus	Measured by nasal swab results	Days: 90 after mupirocin application (Repeated dose part)
Secondary	urinary concentrations of monic acid	Analysis collection urine.	Days: 2 after mupirocin application (Repeated dose part)
Secondary	urinary concentrations of monic acid	Analysis collection urine.	Days: 3 after mupirocin application (Repeated dose part)
Secondary	urinary concentrations of monic acid	Analysis collection urine.	Days: 4 after mupirocin application (Repeated dose part)
Secondary	urinary concentrations of monic acid	Analysis collection urine.	Days: 5 after mupirocin application (Repeated dose part)