Trial record 7 of 49 for:
Open Studies | MRSA
MESS-study MRSA Eradication Study Skåne
This study is currently recruiting participants.
Verified August 2012 by Region Skane
Sponsor:
Region Skane
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT01269541
First received: January 3, 2011
Last updated: August 20, 2012
Last verified: August 2012
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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: | 230 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (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
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 | Recruiting |
| Helsingborg, Skåne, Sweden | |
| Contact: Anna-Karin Larsson, MD anna-karin.a.larsson@skane.se | |
| Kristianstad hospital | Not yet recruiting |
| Kristianstad, Skåne, Sweden | |
| Contact: Henrik Elmrud, MD henrik.elmrud@skane.se | |
| Infectious department SUS Lund | Not yet recruiting |
| Lund, Skåne, Sweden | |
| Contact: Per Åkesson, MD Phd per.akesson@skane.se | |
| Principal Investigator: Per Åkesson, MD Phd | |
| SUS Malmö | Recruiting |
| Malmö, Skåne, Sweden | |
| Contact: Anna Nilsson, MD PhD anna.nilsson@med.lu.se | |
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: | August 20, 2012 |
| Health Authority: | sweden: Läkemedelsverket (Medical products agency) |
Additional relevant MeSH terms:
|
Rifampin Mupirocin Trimethoprim-Sulfamethoxazole Combination Antibiotics, Antitubercular Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antitubercular Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Leprostatic Agents Nucleic Acid Synthesis Inhibitors Anti-Infective Agents, Urinary Renal Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Protein Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013