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

March 21, 2017 updated by: Mercy Research

Comparison of Decolonization of MRSA Using Theraworx

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Economic-Cost comparison of treatment Evidence of decolonization
Time Frame: 5 days of treatment
5 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Research

Investigators

  • Principal Investigator: Roger E Huckfeldt, MD, Mercy/St. John's Hospital - Springfield

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

July 7, 2008

First Submitted That Met QC Criteria

July 10, 2008

First Posted (Estimate)

July 11, 2008

Study Record Updates

Last Update Posted (Actual)

March 23, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJMRSA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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