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

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ClinicalTrials.gov Identifier: NCT00713674
Recruitment Status : Withdrawn (Lack of patient recruitment.)
First Posted : July 11, 2008
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Mercy Research

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

Condition or disease Intervention/treatment Phase
Methicillin-Resistant Staphylococcus Aureus Other: Theraworx Drug: mupirocin antibiotic ointment Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Decolonization of MRSA Using Theraworx
Study Start Date : March 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRSA
U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. Economic-Cost comparison of treatment Evidence of decolonization [ Time Frame: 5 days of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713674


Sponsors and Collaborators
Mercy Research
Investigators
Principal Investigator: Roger E Huckfeldt, MD Mercy/St. John's Hospital - Springfield

Responsible Party: Mercy Research
ClinicalTrials.gov Identifier: NCT00713674     History of Changes
Other Study ID Numbers: SJMRSA-01
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017

Keywords provided by Mercy Research:
Methicillin resistance

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Methicillin
Mupirocin
Antibiotics, Antitubercular
Allantoin
Anti-Infective Agents
Antitubercular Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents