We are investigating the optimal treatment of MRSA carriage in throat
Conditions
Interventions
Trade Name: Clindamycin "Alternova"
Pharmaceutical Form: Capsule, hard
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Sponsors
MRSA Knowlege center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • MRSA carriage in the throat after first topical decolonization treatment (regardless of previous swabs) • Has completed one standard topical decolonization treatment 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Pregnant or lactating woman • Sexually active women in the reproductive age that do not use approved contraceptives (appendix 4) • Cannot read or speak Danish (the written participant information is in Danish) • Skin infection or other active infections • Activity in skin diseases such as eczema or psoriasis. • MRSA isolate with clindamycin zone size 35) or weight < 50 kg • Indwelling percutaneous permanent devices such as intravenous catheters or urinary tract catheters • Daily contact with pigs or minks (decolonization therapy is generally not offered, according to The National Board of Health) • Nursing home resident or health care worker (they have a more frequent control swab regime) • Not being capable of completing another treatment successfully • MRSA positive household members younger than 2 years (MRSA positive children below 2 years of age and their household members are generally not offered decolonization treatment according to The National Board of Health) • MRSA positive household members, where it is judged that further decolonization attempts are not indicated
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoint: MRSA negative swabs after 6 months ;Timepoint(s) of evaluation of this end point: Evaluation of secndary endpoint will be evaluated 6 months after end of the 10 day active study period, with MRSA control swabs. Only those patients who were MRSA negative at 1 month, will have swabs taken at 6 months. Those who were MRSA positive at 1 month have left the trial. | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Antibiotic resistance in bacteria is an increasing challenge worldwide. Methicillin resistant Staphylococcus aureus (MRSA) has been seen since 1961 . S. aureus is an opportunistic pathogen that can become invasive and cause a large spectrum of infections, but can also colonize the skin/mucosa. When colonization is confirmed, the person is called a carrier of MRSA and is at risk of a wide spectrum of infections, as well as giving it to others. The Danish Health Authority has published a National guideline on how to prevent the spread of MRSA using a five day topical decolonization treatment. Unfortunately, many patients are still MRSA carriers after completing the treatment and especially throat carriers are difficult to clear. We wish to investigate if a significantly higher number of MRSA throat carriers become MRSA free when treated with standard treatment plus the antibiotic clindamycin compared to the standard treatment alone. Primary endpoint: MRSA negative swabs at 1 months;Secondary Objective: Secondary endpoint: MRSA negative swabs after 6 months;Primary end point(s): Primary endpoint: MRSA negative swabs at 1 months ;Timepoint(s) of evaluation of this end point: The study will take place Sep 1st 2019 – August 31st 2022. 24 months of including patients and collecting data, 12 months for analysis and publication of data. Evaluation of primary endpoint will take place no later than 60 days after the 10 day active study period, by using MRSA control swabs. | — |
Countries
Denmark
Contacts
Public ContactMRSA Knowlege center
MRSA Knowlege center
Outcome results
None listed