Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368856
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-08
Brief Title:
Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers Monocentric Study
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers Monocentric Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUPIPHARM
Brief 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 applicationsday 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 ie 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 ie 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
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 ie 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-006105-30 | EUDRACT_NUMBER | None | None |