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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This study has been withdrawn prior to enrollment.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 (Responsible Party):
Mercy Research
ClinicalTrials.gov Identifier:
NCT00713674
First received: July 7, 2008
Last updated: March 21, 2017
Last verified: March 2017
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Decolonization of MRSA Using Theraworx

Resource links provided by NLM:


Further study details as provided by Mercy Research:

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

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

Enrollment: 0
Study Start Date: March 2008
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   (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
  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: NCT00713674

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

Responsible Party: Mercy Research
ClinicalTrials.gov Identifier: NCT00713674     History of Changes
Other Study ID Numbers: SJMRSA-01
Study First Received: July 7, 2008
Last Updated: March 21, 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

ClinicalTrials.gov processed this record on August 17, 2017