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Comparison of Decolonization of Methicillin-resistant Staphylococcus Aureus (MRSA) Using Theraworx (SJMRSA)

This study has been withdrawn prior to enrollment.
(Lack of patient recruitment.)
Sponsor:
Information provided by:
St. John's Health System, Missouri
ClinicalTrials.gov Identifier:
NCT00713674
First received: July 7, 2008
Last updated: January 11, 2010
Last verified: July 2008
History of Changes
  Purpose

The purpose of this study is to examine treatment method of Methicillin-resistant Staphylococcus aureus (MRSA) decolonization in patients.


Condition Intervention
Methicillin-resistant Staphylococcus Aureus
 Other: Theraworx
Drug: mupirocin antibiotic ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Decolonization of MRSA Using Theraworx

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by St. John's Health System, Missouri:

Primary Outcome Measures:
  • Evidence of decolonization confirmed by intranasal culture [ Time Frame: Up to 14 days post treatment (+/- 1-2 days) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Economic-Cost comparison of treatment Evidence of decolonization [ Time Frame: 5 days of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2008
Estimated Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No Treatment
Experimental: 2
Theraworx intranasal
 Other: Theraworx
Theraworx swab intranasal BID for 5 days
Active Comparator: 3
mupirocin antibiotic ointment intranasal
 Drug: mupirocin antibiotic ointment
mupirocin antibiotic ointment swab intranasal BID for 5 days

Detailed Description:

Decolonization therapy is indicated for management of patients with MRSA. Theraworx is reported to be an effective antimicrobial against multiple organisms. In this study, patients with positive MRSA colonization culture will be treated with Theraworx to evaluate decolonization duration capability.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Positive MRSA culture

Exclusion Criteria:

  • Patients currently on or start antibiotic therapy directed for MRSA.(Prophylaxis antibiotic for surgical procedure not considered therapy.)
  • Patients with MRSA infected wounds
  • Patients under the age of 18 years
  • A woman currently pregnant or nursing a child
  • Patients participating in another study within 30 days of randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713674

Locations
United States, Missouri
St John's Hospital-Medical Research Institute
Springfield, Missouri, United States, 65804
Sponsors and Collaborators
St. John's Health System, Missouri
Investigators
Principal Investigator: Roger E Huckfeldt, MD St. Johns' Health System-Medical Research Institute
  More Information

No publications provided

Responsible Party: Roger Huckfeldt, MD, St. John's Medical Research Institute
ClinicalTrials.gov Identifier: NCT00713674     History of Changes
Other Study ID Numbers: SJMRSA-01
Study First Received: July 7, 2008
Last Updated: January 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by St. John's Health System, Missouri:
Methicillin resistance

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Methicillin
Mupirocin
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013