MESS-study MRSA Eradication Study Skåne

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Region Skane
Sponsor:
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01269541
First received: January 3, 2011
Last updated: May 25, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention
Throatcarriers of MRSA
Drug: Mupirocin
Drug: Rifampin+Clindamycine or Trimehoprimsulfa

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MESS- MRSA Eradication Study Skåne. A Comparison Between Systemic Antibiotic Treatment in Combination With Topical Mupirocintreatment With Only Topical Mupiroicintreatment to Eradicate MRSA in Throat Carriers

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Culture for MRSA [ Time Frame: after 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 69
Study Start Date: March 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mupirocin
Topical treatment
Drug: Mupirocin
Topical in the nose 3 times daily for 5 days
Drug: Rifampin+Clindamycine or Trimehoprimsulfa
Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2
Active Comparator: Rifampicin+Clindamycine or Trimethoprimsulfa
Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3xVII Trimethoprimsulfa 400mg/80mg 2x2
Drug: Rifampin+Clindamycine or Trimehoprimsulfa
Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269541

Contacts
Contact: Eva Melander, MD Phd +4640-33 74 86 eva.z.melander@skane.se
Contact: Anna-Karin Larsson, MD +464062950 anna-karin.a.larsson@skane.se

Locations
Sweden
Helsingborg hospital Completed
Helsingborg, Skåne, Sweden
Kristianstad hospital Completed
Kristianstad, Skåne, Sweden
Infectious department SUS Lund Completed
Lund, Skåne, Sweden
SUS Malmö Recruiting
Malmö, Skåne, Sweden
Contact: Anna Nilsson, MD PhD       anna.nilsson@med.lu.se   
Principal Investigator: Anna Nilsson, MD, PhD         
Karolinska university hospital Completed
Stockholm, Sweden
Örebro university hospital Completed
Örebro, Sweden
Sponsors and Collaborators
Region Skane
Investigators
Principal Investigator: Eva Melander, MD PHD Labmedicin Skåne Malmö
  More Information

No publications provided

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01269541     History of Changes
Other Study ID Numbers: MRSA-2010, 2010-019727-55
Study First Received: January 3, 2011
Last Updated: May 25, 2015
Health Authority: sweden: Läkemedelsverket (Medical products agency)

Additional relevant MeSH terms:
Mupirocin
Trimethoprim-Sulfamethoxazole Combination
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015