The Natural History of Community-Associated MRSA Infections and Decolonization Strategies (StLStaRS)

July 7, 2015 updated by: Stephanie A. Fritz, Washington University School of Medicine

The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies

The purpose of this study is to determine the natural history of community-associated Staphylococcus aureus infections in both adult and pediatric patients by monitoring the rate of recurrent infections in those colonized with S. aureus.

In addition, this study will evaluate the efficiency of commonly prescribed decolonization measures in patients presenting with S. aureus skin and soft tissue infections.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infections with community-associated methicillin-resistant Staphylococcus aureus (CA-MRSA) range in severity from superficial skin abscesses to invasive soft tissue infections like cellulitis and pyomyositis. There has been a large increase in the number of patients presenting to our institution with CA-MRSA infections. Colonization with S. aureus (SA) may be linked to the development of infection but data on this phenomenon are limited. The recurrence rate for CA-MRSA soft tissue infections is unknown. A variety of decolonization strategies have been used for infection prophylaxis with varying results, primarily in patients undergoing hemodialysis or surgery. This study seeks to determine the recurrence rate of soft tissue infections among patients with CA-MRSA infections and to determine a reasonable and efficacious decolonization strategy to eradicate CA-MRSA from previously infected patients.

The proposed methods for decolonization will be tested in a randomized controlled trial with four intervention arms. The intervention arms are: (1) intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group"), (2) application of mupirocin in the nasal mucosa alone, (3) a combination of nasal application of mupirocin and chlorhexidine showers, and (4) a combination of nasal application of mupirocin and bathing in dilute bleach water. The "control" group as well as the three other arms will receive intensive hygiene education.

Decolonization with mupirocin ointment and chlorhexidine showers or dilute bleach baths in combination are likely to be more successful than either the application of nasal mupirocin ointment alone or hygiene measures alone. It is expected that these decolonization methods will result in a 50% relative reduction in MRSA colonization at 6 months.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
      • St. Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital

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

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient who presents with at least one serious skin or soft tissue infection requiring incision and drainage at an affiliated institution or clinic in the St. Louis metropolitan area

Exclusion Criteria:

  • Patients with permanent indwelling catheters or percutaneous medical devices
  • Patients with a history of dialysis treatments, long term care facility admission, or presents with a surgical wound infection within the past year
  • Patients who are pregnant

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1: Hygiene Education
Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
Behavioral: Intensive education on personal hygiene
Repeat hygiene methods for 5 days.
ACTIVE_COMPARATOR: 2: Hygiene education + mupirocin
Application of mupirocin in the nasal mucosa alone
Behavioral: Intensive education on personal hygiene
Repeat hygiene methods for 5 days.
Drug: Mupirocin ointment
Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Other Names:
  • Bactroban
ACTIVE_COMPARATOR: Education + mupirocin + chlorhexidine
A combination of nasal application of mupirocin and chlorhexidine showers
Behavioral: Intensive education on personal hygiene
Repeat hygiene methods for 5 days.
Drug: Mupirocin ointment
Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Other Names:
  • Bactroban
Genetic: Chlorhexidine showers
Apply Clorhexidine wash to entire body once daily for 5 days.
Other Names:
  • Hibiclens
ACTIVE_COMPARATOR: 4: Education + mupirocin + bleach baths
A combination of nasal application of mupirocin and bathing in dilute bleach water
Behavioral: Intensive education on personal hygiene
Repeat hygiene methods for 5 days.
Drug: Mupirocin ointment
Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.
Other Names:
  • Bactroban
Procedure: Bleach baths (dilute)
Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.
Other Names:
  • Clorox

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention
Time Frame: 1 month follow-up
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
1 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
Time Frame: 1, 4 and 6 month follow-ups
Recurrent Staphylococcus aureus Skin or Soft Tissue Infection is defined as incidence of skin abscess, impetigo, cellulitis, or spider bite in the 1 month following intervention. Infections reported by participant at follow-up visit.
1, 4 and 6 month follow-ups
Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
Time Frame: 4 month follow-up
Eradication is defined as the absence of S. aureus carriage at the 3 sampled body sites (anterior nares, axilla, inguinal folds) of the index patient. Samples obtained by study team at follow-up visit.
4 month follow-up

Collaborators and Investigators

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

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Bernard C. Camins, MD, MSCR, Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine
  • Principal Investigator: Gregory A. Storch, MD, Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2007

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

August 8, 2007

First Submitted That Met QC Criteria

August 8, 2007

First Posted (ESTIMATE)

August 9, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

July 30, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9000C4

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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