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

This study has been completed.
Sponsor:
Information provided by:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00513799
First received: August 8, 2007
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Abscesses
Furunculosis
Staphylococcus Aureus Infection
Staphylococcal Skin Infections
Drug: Mupirocin ointment
Genetic: Chlorhexidine showers
Procedure: Bleach baths (dilute)
Behavioral: Intensive education on personal hygiene

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention [ Time Frame: 1 month follow-up ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection [ Time Frame: 1, 4 and 6 month follow-ups ] [ Designated as safety issue: No ]
    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.

  • Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention [ Time Frame: 4 month follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: March 2007
Study Completion Date: December 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: Bactroban
Behavioral: Intensive education on personal hygiene
Repeat hygiene methods for 5 days.
Active Comparator: Education + mupirocin + chlorhexidine
A combination of nasal application of mupirocin and chlorhexidine showers
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 Name: Bactroban
Genetic: Chlorhexidine showers
Apply Clorhexidine wash to entire body once daily for 5 days.
Other Name: Hibiclens
Behavioral: Intensive education on personal hygiene
Repeat hygiene methods for 5 days.
Active Comparator: 4: Education + mupirocin + bleach baths
A combination of nasal application of mupirocin and bathing in dilute bleach water
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 Name: 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 Name: Clorox
Behavioral: Intensive education on personal hygiene
Repeat hygiene methods for 5 days.

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.

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00513799

Locations
United States, Missouri
Barnes-Jewish Hospital
St. Louis, Missouri, United States, 63110
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
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
  More Information

No publications provided by Washington University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernard Camins, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00513799     History of Changes
Other Study ID Numbers: 9000C4
Study First Received: August 8, 2007
Results First Received: March 2, 2011
Last Updated: March 31, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Abscess
Furunculosis
Skin Diseases, Infectious
Staphylococcal Skin Infections
Staphylococcal Infections
Suppuration
Infection
Inflammation
Pathologic Processes
Gram-Positive Bacterial Infections
Bacterial Infections
Skin Diseases, Bacterial
Skin Diseases
Chlorhexidine
Chlorhexidine gluconate
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 23, 2014