Treatment of patients with MRSA bacteria in their throat by irrigation with the drug mupiroci
Phase 1
- Conditions
- Patientents being MRSA positive for a minimum of 6 months and concluded at least one konventional topical treatments unsuccessfullyMedDRA version: 20.0Level: PTClassification code 10061554Term: Staphylococcal pharyngitisSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2014-005308-12-DK
- Lead Sponsor
- Region Sjælland, Slagelse Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
MRSA positive for a minimum of 6 months
Completed at least one conventional topical treatments without success.
18 years of age or above and able to consent
The S.aureus isolat is mupirocin sensitive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
Sufforing from acute or chronic ilness in the ear, nose or throat
Sensitive to mupirocin
Risk of re-infection from environment (work, living conditions - eg work or living at a pig farm)
Negative
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Aim<br>•To investigate whether nasopharyngeal carriers of MRSA are decolonised for MRSA by combining the konventional topical MRSA reatment with rhinopharynx irrigation with mupirocin <br><br>;Secondary Objective: To investigate if the treatment regimen can be used as first line tratment in newly diagnosed patients carrying MRSA in their throat ;Primary end point(s): Free of MRSA after 1 month (plus/minus 1 week), and free of MRSA after a minimum of 6 months;Timepoint(s) of evaluation of this end point: 1 month and 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Same;Timepoint(s) of evaluation of this end point: 1 month and 6 months