Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

MESS-study MRSA Eradication Study Skåne (MESS)

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   (Child, Adult, Senior)
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

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:
Rifampin
Mupirocin
Trimethoprim, Sulfamethoxazole Drug Combination
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Protein Synthesis Inhibitors
Anti-Infective Agents, Urinary
Renal Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on December 08, 2016