MESS-study MRSA Eradication Study Skåne | NCT01269541

Studies
MESS-study MRSA Eradication Study Skåne

NCT01269541

Sponsor

Region Skane

Status

Completed

Last Update Posted

Aug 22, 2017Actual

Enrollment

69Actual

Phase

Not Applicable

Conditions

Throatcarriers of MRSA

Interventions

Mupirocin
Rifampin+Clindamycine or Trimehoprimsulfa

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2010-019727-55	EudraCT Number

Status Module

Record Verification Date

May 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2011Actual

Primary Completion Date

May 1, 2015Actual

Completion Date

May 1, 2015Actual

First Submitted Date

Jan 3, 2011

First Submission Date that Met QC Criteria

Jan 3, 2011

First Posted Date

Jan 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2017

Last Update Posted Date

Aug 22, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mupirocin	Active Comparator	Topical treatment	Drug: Mupirocin Drug: 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

Name	Type	Description	Arm Group Labels	Other Names
Mupirocin	Drug	Topical in the nose 3 times daily for 5 days	Mupirocin

Measure	Description	Time Frame
Culture for MRSA		after 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Eva Melander, MD PHD	Labmedicin Skåne Malmö	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsingborg hospital		Helsingborg	Skåne County		Sweden
Kristianstad hospital

Intervention Browse Module

MeSH Terms

ID	Term
D016712	Mupirocin

Ancestor Terms

ID	Term
D004852	Epoxy Compounds
D004988	Ethers, Cyclic
D004987	Ethers
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided