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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abscesses Furunculosis Staphylococcus Aureus Staphylococcal Skin Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1: Hygiene Education

Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")

Group Type ACTIVE_COMPARATOR

Intensive education on personal hygiene

Intervention Type BEHAVIORAL

Repeat hygiene methods for 5 days.

2: Hygiene education + mupirocin

Application of mupirocin in the nasal mucosa alone

Group Type ACTIVE_COMPARATOR

Mupirocin ointment

Intervention Type DRUG

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.

Intensive education on personal hygiene

Intervention Type BEHAVIORAL

Repeat hygiene methods for 5 days.

Education + mupirocin + chlorhexidine

A combination of nasal application of mupirocin and chlorhexidine showers

Group Type ACTIVE_COMPARATOR

Mupirocin ointment

Intervention Type DRUG

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.

Chlorhexidine showers

Intervention Type GENETIC

Apply Clorhexidine wash to entire body once daily for 5 days.

Intensive education on personal hygiene

Intervention Type BEHAVIORAL

Repeat hygiene methods for 5 days.

4: Education + mupirocin + bleach baths

A combination of nasal application of mupirocin and bathing in dilute bleach water

Group Type ACTIVE_COMPARATOR

Mupirocin ointment

Intervention Type DRUG

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.

Bleach baths (dilute)

Intervention Type PROCEDURE

Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.

Intensive education on personal hygiene

Intervention Type BEHAVIORAL

Repeat hygiene methods for 5 days.

Interventions

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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.

Intervention Type DRUG

Chlorhexidine showers

Apply Clorhexidine wash to entire body once daily for 5 days.

Intervention Type GENETIC

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.

Intervention Type PROCEDURE

Intensive education on personal hygiene

Repeat hygiene methods for 5 days.

Intervention Type BEHAVIORAL

Other Intervention Names

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Bactroban Hibiclens Clorox

Eligibility Criteria

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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

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Stephanie A. Fritz

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernard C. Camins, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine

Gregory A. Storch, MD

Role: PRINCIPAL_INVESTIGATOR

Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine