NCT01269541

Brief Summary

The purpose of this study is to determine whether systemic antibiotic treatment with rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 22, 2017

Status Verified

May 1, 2015

Enrollment Period

4.2 years

First QC Date

January 3, 2011

Last Update Submit

August 21, 2017

Conditions

Throatcarriers of MRSA

Outcome Measures

Primary Outcomes (1)

  • Culture for MRSA

    after 6 months

Study Arms (2)

Mupirocin

ACTIVE COMPARATOR

Topical treatment

Drug: MupirocinDrug: Rifampin+Clindamycine or Trimehoprimsulfa

Rifampicin+Clindamycine or Trimethoprimsulfa

ACTIVE COMPARATOR

Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3xVII Trimethoprimsulfa 400mg/80mg 2x2

Drug: Rifampin+Clindamycine or Trimehoprimsulfa

Interventions

MupirocinDRUG

Topical in the nose 3 times daily for 5 days

Mupirocin
Rifampin+Clindamycine or TrimehoprimsulfaDRUG

Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2

MupirocinRifampicin+Clindamycine or Trimethoprimsulfa

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Colonized with MRSA in the throat Older than 5 years MRSA-bacteria sensitive for Rifampicin and Clindamycine or Trimethoprimsulfa -

You may not qualify if:

  • Allergy to the studymedication Healthcareworkers Pregnancy Active infection with MRSA Immunosuppression Treatment with other antibiotic during the studyperiod

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Helsingborg hospital

Helsingborg, Skåne County, Sweden

Location

Kristianstad hospital

Kristianstad, Skåne County, Sweden

Location

Infectious department SUS Lund

Lund, Skåne County, Sweden

Location

SUS Malmö

Malmo, Skåne County, Sweden

Location

Örebro university hospital

Örebro, Sweden

Location

Karolinska university hospital

Stockholm, Sweden

Location

MeSH Terms

Interventions

Mupirocin

Intervention Hierarchy (Ancestors)

Epoxy CompoundsEthers, CyclicEthersOrganic ChemicalsPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFatty AcidsLipids

Study Officials

  • Eva Melander, MD PHD

    Labmedicin Skåne Malmö

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 4, 2011

Study Start

March 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

August 22, 2017

Record last verified: 2015-05

Locations

SE(6)