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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Hovedstaden

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

completed 31 Aug 2025

Decision date (initial)

2024-10-23

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-516377-69-01

EudraCT number

2019-002631-29

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The main objective of this RCT is to investigate whether adding peroral clindamycin to the standard decolonization treatment with mupirocin nasal ointment and chlorhexidin body wash significantly improves the treatment success rate of MRSA throat carriers.

Conditions and MedDRA coding

MRSA throat carriage

Regulatory references

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Age ≥ 18 years
2. MRSA carriage in the throat
3. Has completed one standard topical decolonization treatment

Exclusion criteria 17

1. Pregnant or lactating woman
2. Sexually active women in the reproductive age that do not use approved contraceptives
3. Cannot read or speak Danish or English
4. Skin infection or other active infections
5. Activity in skin diseases such as eczema or psoriasis
6. MRSA isolate resistant to clindamycin (defined by inhibition zone size < 22 mm using disk diffusion methodology) or resistant to mupirocin
7. Allergy to clindamycin, chlorhexidine or mupirocin
8. Taking medications that interact with clindamycin according to the medicine information leaflet.
9. MRSA active antibiotic treatment within 7 days before inclusion in the study or during study period
10. Followed by specialist due to liver disease
11. Severe overweight (BMI > 35) or weight < 50 kg
12. Indwelling percutaneous permanent devices such as intravenous catheters or urinary tract catheters
13. Daily contact with pigs or minks (decolonization therapy is generally not offered, according to The National Board of Health)
14. Nursing home resident or health care worker (they have a more frequent control swab regime)
15. Not being capable of completing another treatment successfully
16. 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)
17. MRSA positive household members, where it is judged that further decolonization attempts are not indicated

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. MRSA negative swabs at 1 months

Secondary endpoints 1

1. MRSA negative swabs after 6 months

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Hovedstaden

Sponsor organisation

Region Hovedstaden

Address

Kettegaard Alle 30

City

Hvidovre

Postcode

2650

Country

Denmark

Scientific contact point

Organisation

Hvidovre Hospital

Contact name

Mette Damkjær Bartels

Public contact point

Organisation

Hvidovre Hospital

Contact name

Mette Damkjær Bartels

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications