MRSA Clinical Trial
Official title:
A Randomized Placebo-controlled Double-blinded Trial of the Treatment of MRSA Throat Carriage With Either Standard Decolonization Therapy or Standard Decolonization Therapy Combined With Oral Clindamycin
The aim of this study is to investigate the optimal way to treat MRSA throat carriers.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2032 |
Est. primary completion date | September 30, 2032 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - MRSA carriage in the throat after first topical decolonization treatment (regardless of previous swab results) - Has completed one standard topical decolonization treatment 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 resistant to clindamycin (defined by inhibition zone size < 22 mm using disk diffusion methodology) or resistant to mupirocin - Allergy to clindamycin, chlorhexidine or mupirocin - Taking medications that interact with clindamycin according to the medicine information leaflet. - MRSA active antibiotic treatment within 7 days before inclusion in the study or during study period - Followed by specialist due to liver disease - Severe overweight (BMI > 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
6.Henius AE, Pedersen K, Jensen LB. Danmap 2017. 2017
Authority DH. Guidance on Preventing the Spread of MRSA. December 13. 2016. p. ISBN online: 978-87-7104-854-4
Bagge K, Benfield T, Westh H, Bartels MD. Eradicating MRSA carriage: the impact of throat carriage and Panton-Valentine leukocidin genes on success rates. Eur J Clin Microbiol Infect Dis. 2019 Apr;38(4):683-688. doi: 10.1007/s10096-019-03474-6. Epub 2019 Jan 25. — View Citation
JEVONS MP, COE AW, PARKER MT. Methicillin resistance in staphylococci. Lancet. 1963 Apr 27;1(7287):904-7. doi: 10.1016/s0140-6736(63)91687-8. No abstract available. — View Citation
Kluytmans J, van Belkum A, Verbrugh H. Nasal carriage of Staphylococcus aureus: epidemiology, underlying mechanisms, and associated risks. Clin Microbiol Rev. 1997 Jul;10(3):505-20. doi: 10.1128/CMR.10.3.505. — View Citation
Lowy FD. Staphylococcus aureus infections. N Engl J Med. 1998 Aug 20;339(8):520-32. doi: 10.1056/NEJM199808203390806. No abstract available. — View Citation
VandenBergh MF, Yzerman EP, van Belkum A, Boelens HA, Sijmons M, Verbrugh HA. Follow-up of Staphylococcus aureus nasal carriage after 8 years: redefining the persistent carrier state. J Clin Microbiol. 1999 Oct;37(10):3133-40. doi: 10.1128/JCM.37.10.3133-3140.1999. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRSA negative swabs at 1 month | MRSA negative swabs at 1 month | 30-60 days after treatment | |
Secondary | MRSA negative swabs after 6 months | MRSA negative swabs after 6 months | 6-8 months after treatment |
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