Optimal Treatment of MRSA Throat Carriers

NCT04104178 | Completed Phase 3 DMC

• 1 other identifier: MRSATHROAT_2019
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to investigate the optimal way to treat MRSA throat carriers.

Conditions

MRSA; MRSA Colonization

Outcome Measures

Primary Outcomes (1)

• MRSA negative swabs at 1 month

  MRSA negative swabs at 1 month

  30-60 days after treatment

Secondary Outcomes (1)

• MRSA negative swabs after 6 months

  6-8 months after treatment

Study Arms (2)

Clindamycin

ACTIVE COMPARATOR

600 mg clindamycin, 3 times daily for 10 days, orally

Drug: Clindamycin

Placebo

PLACEBO COMPARATOR

Arm consumes placebo capsules identical to clincamycin capsuls from the other arm,3 times daily for 10 days, orally

Drug: Placebo

Interventions

Clindamycin DRUG

Investigating whether a significantly higher number of MRSA throat carriers succeed in becoming MRSA free, when using Clindamycin on top of our general recommended topical treatment of Mupirocin nasal ointment + chorhexidin baths

Also known as: Dalamycin

Clindamycin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre Hospital

Hvidovre, Denmark

Location

Related Publications (7)

• 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.

  PMID: 10488166 BACKGROUND

• 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.

  PMID: 9227864 BACKGROUND

• 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.

  PMID: 13957735 BACKGROUND

• Lowy FD. Staphylococcus aureus infections. N Engl J Med. 1998 Aug 20;339(8):520-32. doi: 10.1056/NEJM199808203390806. No abstract available.

  PMID: 9709046 BACKGROUND

• Authority DH. Guidance on Preventing the Spread of MRSA. December 13. 2016. p. ISBN online: 978-87-7104-854-4

  BACKGROUND

• 6.Henius AE, Pedersen K, Jensen LB. Danmap 2017. 2017

  BACKGROUND

• 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.

  PMID: 30684163 BACKGROUND

MeSH Terms

Interventions

Clindamycin

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• Mona KA Holm, MD

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: It's a double blinded placebo study. Only the pharmacy knows the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinating Principal Investigator

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: September 26, 2019
• Study Start: May 20, 2020
• Primary Completion: September 18, 2025
• Study Completion: September 18, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)