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

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The Washington University

Status

Completed

Conditions

Abscesses
Staphylococcal Skin Infections
Furunculosis
Staphylococcus Aureus

Treatments

Drug: Mupirocin ointment
Procedure: Bleach baths (dilute)
Behavioral: Intensive education on personal hygiene
Genetic: Chlorhexidine showers

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

6+ months old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

300 participants in 4 patient groups

1: Hygiene Education
Active Comparator group
Description:
Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as "control group")
Treatment:
Behavioral: Intensive education on personal hygiene
2: Hygiene education + mupirocin
Active Comparator group
Description:
Application of mupirocin in the nasal mucosa alone
Treatment:
Behavioral: Intensive education on personal hygiene
Drug: Mupirocin ointment
Education + mupirocin + chlorhexidine
Active Comparator group
Description:
A combination of nasal application of mupirocin and chlorhexidine showers
Treatment:
Genetic: Chlorhexidine showers
Behavioral: Intensive education on personal hygiene
Drug: Mupirocin ointment
4: Education + mupirocin + bleach baths
Active Comparator group
Description:
A combination of nasal application of mupirocin and bathing in dilute bleach water
Treatment:
Behavioral: Intensive education on personal hygiene
Procedure: Bleach baths (dilute)
Drug: Mupirocin ointment

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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