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MRSA decolonization in complicated carriage - cluster randomized trial

MRSA decolonization in complicated carriage - cluster randomized trial - CLEANEST

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51735
Enrollment
201
Registered
2022-03-28
Start date
2022-05-02
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRSA carriership - Methicillin resistant Staphylococcus aureus carriership

Interventions

Group A: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. versus Group B: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. All orally, total duration 7 days.

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: complicated MRSA carriership Adult

Exclusion criteria

Exclusion criteria: - catheters/drains in situ - Failure of previous decolonization attempt of complicated MRSA carriage - Allergy or other contra-indication to either doxycycline, rifampicin or trimethoprim (these patients will participate in the observational arm) - Previous participation in this study - Pregnancy

Design outcomes

Primary

MeasureTime frame
The main study endpoint is the success rate of MRSA decolonization. Successful decolonization is defined as 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.

Secondary

MeasureTime frame
- The long-term success rate of decolonization treatment of doxycycline-rifampicin compared to trimethoprim-rifampicin, defined as an additional set of negative MRSA swabs taken 2 months and 1 year after decolonization treatment. - To determine whether there is an association between virulence factors and success rate of decolonization.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)