Clinical trial NCT00513799: The Natural History of Community-Associated MRSA Infections and Decolonization Strategies
Official title: The Natural History of Community-Associated Methicillin-Resistant Staphylococcus Aureus (CA-MRSA) Infections and an Evaluation of Decolonization Strategies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abscesses
Furunculosis
Staphylococcus Aureus
Staphylococcal Skin Infections
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2007-08-09
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention
timeFrame: 1 month follow-up
Secondary outcomes:
measure: Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection
timeFrame: 1, 4 and 6 month follow-ups
measure: Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention
timeFrame: 4 month follow-up
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
city: St. Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Assistant Professor of Medicine, Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine
name: Bernard C. Camins, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor of Medicine and Molecular Microbiology, Chief of Division of Pediatric Infectious Diseases, Department of Medicine, Washington University School of Medicine
name: Gregory A. Storch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fritz SA, Camins BC, Eisenstein KA, Fritz JM, Epplin EK, Burnham CA, Dukes J, Storch GA. Effectiveness of measures to eradicate Staphylococcus aureus carriage in patients with community-associated skin and soft-tissue infections: a randomized trial. Infect Control Hosp Epidemiol. 2011 Sep;32(9):872-80. doi: 10.1086/661285.