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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-006105-30 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose part : 50mg mupirocin | Active Comparator | - Single dose part = single dose of 50 mg mupirocin in each nostril |
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| Single dose part : 500mg mupirocin | Experimental | Single dose part = single dose of 500 mg mupirocin in each nostril |
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| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mupirocin (50 mg) | Drug | 50 mg de mupirocin |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma concentrations of mupirocin | mupirocin pharmacokinetics | 0 hours 30 after mupirocin application (Single dose part) |
| plasma concentrations of mupirocin | mupirocin pharmacokinetics | 1 hours after mupirocin application (Single dose part) |
| plasma concentrations of mupirocin | mupirocin pharmacokinetics | 2 hours after mupirocin application (Single dose part) |
| intranasal concentrations of mupirocin | mupirocin pharmacokinetics | 1 hours after mupirocin application (Single dose part) |
| intranasal concentrations of mupirocin | mupirocin pharmacokinetics | 2 hours after mupirocin application (Single dose part) |
| intranasal concentrations of mupirocin | mupirocin pharmacokinetics | 4 hours after mupirocin application (Single dose part) |
| intranasal concentrations of mupirocin | mupirocin pharmacokinetics | 6 hours after mupirocin application (Single dose part) |
| intranasal concentrations of mupirocin | mupirocin pharmacokinetics |
| Measure | Description | Time Frame |
|---|---|---|
| presence of Staphylococcus aureus | Measured by nasal swab results | Days: 5 after mupirocin application (Repeated dose part) |
| presence of Staphylococcus aureus | Measured by nasal swab results |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kasra AZARNOUSH, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de SAINT-ETIENNE | Saint-Etienne | France |
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Single-center, randomized, open-label pharmacokinetic study of mupirocin in 40 healthy subjects with 2 randomization :
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| 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 |
|
| 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 |
|
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| Mupirocin (500 mg) | Drug | 500 mg de mupirocin |
|
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| blood samples after Single dose part | Biological | 3 blood samples will be performed sampling time ater application of mupirocin (single dose part): 00h30, 1h00, 02h00 |
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| nasal swab after Single dose part | Diagnostic Test | 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 |
|
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| Collection of urine after Single dose part | Other | Collection of urine during 12 hours after the application of mupirocin (Single dose part) |
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| nasal swab during Repeated dose part | Diagnostic 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 part | Other | 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 | Other | 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) |
|
| 8 hours after mupirocin application (Single dose part) |
| intranasal concentrations of mupirocin | mupirocin pharmacokinetics | 12 hours after mupirocin application (Single dose part) |
| Days: 6 after mupirocin application (Repeated dose part) |
| presence of Staphylococcus aureus | Measured by nasal swab results | Days: 30 after mupirocin application (Repeated dose part) |
| presence of Staphylococcus aureus | Measured by nasal swab results | Days: 90 after mupirocin application (Repeated dose part) |
| urinary concentrations of monic acid | Analysis collection urine. | Days: 2 after mupirocin application (Repeated dose part) |
| urinary concentrations of monic acid | Analysis collection urine. | Days: 3 after mupirocin application (Repeated dose part) |
| urinary concentrations of monic acid | Analysis collection urine. | Days: 4 after mupirocin application (Repeated dose part) |
| urinary concentrations of monic acid | Analysis collection urine. | Days: 5 after mupirocin application (Repeated dose part) |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D016712 | Mupirocin |
| ID | Term |
|---|---|
| D004852 | Epoxy Compounds |
| D004988 | Ethers, Cyclic |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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