HealthyPhase 1MUPIPHARMNCT06368856
Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study
A Phase 1 study testing Mupirocin (50 mg), Mupirocin (500 mg) and blood samples after Single dose part in people with Healthy and Staphylococcus Aureus Infection, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Staphylococcus Aureus Infection
- What is being tested?
- Mupirocin (50 mg), Mupirocin (500 mg) and blood samples after Single dose part
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 29 Feb 2024to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject affiliated or entitled to a social security plan
- Subject having signed the consent to participate in the study
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Healthy, Staphylococcus Aureus Infection
- Being tested
- Mupirocin (50 mg), Mupirocin (500 mg), blood samples after Single dose part, nasal swab after Single dose part, Collection of urine after Single dose part
- Keywords
- Staphylococcus Aureus, Mupirocin, Pharmacokinetic
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mupirocin (50 mg)Drug
Also called Bactroban
50 mg de mupirocin
Mupirocin (500 mg)Drug
Also called Bactroban
500 mg de mupirocin
blood samples after Single dose partBiological
3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00
nasal swab after Single dose partDiagnostic test
Also called intranasal concentrations
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 partOther
Collection of urine during 12 hours after the application of mupirocin (Single dose part)
nasal swab during Repeated dose partDiagnostic test
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 partOther
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 partOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Single dose part : 50mg mupirocin | Active comparator | - Single dose part = single dose of 50 mg mupirocin in each nostril Receives: 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 : 500mg mupirocin | Experimental | Single dose part = single dose of 500 mg mupirocin in each nostril Receives: 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 |
| Repeated dose part: Group 1 - 50 mg of mupirocin twice a day | Experimental | 50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days Receives: 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 |
| Repeated dose part: Group 2 50 mg of mupirocin 3 times a day | Experimental | 50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days Receives: 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 |
| Repeated dose part: Group 3 500 mg of mupirocin twice a day | Experimental | 500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days Receives: 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 |
| Repeated dose part: Group 4 500 mg of mupirocin 3 times a day | Experimental | 500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 0 hours 30 after mupirocin application (Single dose part)
plasma concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 1 hours after mupirocin application (Single dose part)
plasma concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 2 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 1 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 2 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 4 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 6 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 8 hours after mupirocin application (Single dose part)
intranasal concentrations of mupirocin
mupirocin pharmacokinetics
Measured: 12 hours after mupirocin application (Single dose part)
Secondary outcomes (8)
presence of Staphylococcus aureus
Measured by nasal swab results
Measured: Days: 5 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Measured by nasal swab results
Measured: Days: 6 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Measured by nasal swab results
Measured: Days: 30 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Measured by nasal swab results
Measured: Days: 90 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Measured: Days: 2 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Measured: Days: 3 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Measured: Days: 4 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Analysis collection urine.
Measured: Days: 5 after mupirocin application (Repeated dose part)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start29 Feb 2024
- Primary completion4 Mar 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kasra AZARNOUSH, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368856
- Sponsor's protocol ID
- 20CH024
- Other IDs
- 2020-006105-30
- Acronym
- MUPIPHARM
- Status last verified
- Jun 2025
- First submitted
- 8 Apr 2024
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study
- ClinicalTrials.gov ID
- NCT06368856
- Acronym / sponsor ID
- MUPIPHARM / 20CH024
- Conditions
- Healthy, Staphylococcus Aureus Infection
- Keywords
- Staphylococcus Aureus, Mupirocin, Pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Single dose part : 50mg mupirocin | Active comparator | 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 50 mg mupirocin in each nostril |
| Single dose part : 500mg mupirocin | Experimental | 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 partSingle dose part = single dose of 500 mg mupirocin in each nostril |
| Repeated dose part: Group 1 - 50 mg of mupirocin twice a day | Experimental | 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 part50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days |
| Repeated dose part: Group 2 50 mg of mupirocin 3 times a day | Experimental | 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 part50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days |
| Repeated dose part: Group 3 500 mg of mupirocin twice a day | Experimental | 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 part500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days |
| Repeated dose part: Group 4 500 mg of mupirocin 3 times a day | Experimental | 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 part500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject affiliated or entitled to a social security plan
- Subject having signed the consent to participate in the study
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mupirocin (50 mg)Also: Bactroban50 mg de mupirocin | Drug | Repeated dose part: Group 1 - 50 mg of mupirocin twice a day, Repeated dose part: Group 2 50 mg of mupirocin 3 times a day, Single dose part : 50mg mupirocin |
| Mupirocin (500 mg)Also: Bactroban500 mg de mupirocin | Drug | Repeated dose part: Group 3 500 mg of mupirocin twice a day, Repeated dose part: Group 4 500 mg of mupirocin 3 times a day, Single dose part : 500mg mupirocin |
| blood samples after Single dose part3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00 | Biological | Single dose part : 500mg mupirocin, Single dose part : 50mg mupirocin |
| nasal swab after Single dose partAlso: intranasal concentrations7 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 | Diagnostic test | Single dose part : 500mg mupirocin, Single dose part : 50mg mupirocin |
| Collection of urine after Single dose partCollection of urine during 12 hours after the application of mupirocin (Single dose part) | Other | Single dose part : 500mg mupirocin, Single dose part : 50mg mupirocin |
| nasal swab during Repeated dose part5 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) | Diagnostic test | Repeated dose part: Group 1 - 50 mg of mupirocin twice a day, Repeated dose part: Group 2 50 mg of mupirocin 3 times a day, Repeated dose part: Group 3 500 mg of mupirocin twice a day, Repeated dose part: Group 4 500 mg of mupirocin 3 times a day |
| Collection of urine during Repeated dose part5 collections of urine during Repeated dose part: 2, 3, 4, 5 et 6 days after the first application of mupirocin (Repeated dose part) | Other | Repeated dose part: Group 1 - 50 mg of mupirocin twice a day, Repeated dose part: Group 2 50 mg of mupirocin 3 times a day, Repeated dose part: Group 3 500 mg of mupirocin twice a day, Repeated dose part: Group 4 500 mg of mupirocin 3 times a day |
| nasal swab after Repeated dose part2 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 | Repeated dose part: Group 1 - 50 mg of mupirocin twice a day, Repeated dose part: Group 2 50 mg of mupirocin 3 times a day, Repeated dose part: Group 3 500 mg of mupirocin twice a day, Repeated dose part: Group 4 500 mg of mupirocin 3 times a day |
Primary outcome
plasma concentrations of mupirocin
Time frame: 0 hours 30 after mupirocin application (Single dose part)
mupirocin pharmacokinetics
plasma concentrations of mupirocin
Time frame: 1 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
plasma concentrations of mupirocin
Time frame: 2 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
intranasal concentrations of mupirocin
Time frame: 1 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
intranasal concentrations of mupirocin
Time frame: 2 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
intranasal concentrations of mupirocin
Time frame: 4 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
intranasal concentrations of mupirocin
Time frame: 6 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
intranasal concentrations of mupirocin
Time frame: 8 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
intranasal concentrations of mupirocin
Time frame: 12 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
8 secondary outcomes
presence of Staphylococcus aureus
Time frame: Days: 5 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Time frame: Days: 6 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Time frame: Days: 30 after mupirocin application (Repeated dose part)
presence of Staphylococcus aureus
Time frame: Days: 90 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Time frame: Days: 2 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Time frame: Days: 3 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Time frame: Days: 4 after mupirocin application (Repeated dose part)
urinary concentrations of monic acid
Time frame: Days: 5 after mupirocin application (Repeated dose part)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kasra AZARNOUSH, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mupirocin (50 mg), Mupirocin (500 mg) and blood samples after Single dose part in people with Healthy and Staphylococcus Aureus Infection, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma concentrations of mupirocin (time frame: 0 hours 30 after mupirocin application (Single dose part)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.