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

Staphylococcus Aureus Clinical Trial

— StLStaRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00513799
• Other study ID #: 9000C4
• Status: Completed
• Phase: N/A
• First received: August 8, 2007
• Last updated: July 7, 2015
• Start date: March 2007
• Est. completion date: December 2010

Study information

• Verified date: July 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: December 2010
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abscesses
• Furunculosis
• Infection
• Skin Diseases, Infectious
• Staphylococcal Skin Infections
• Staphylococcus Aureus

Intervention

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.

Genetic:
• Chlorhexidine showers
Apply Clorhexidine wash to entire body once daily for 5 days.

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.

Behavioral:
• Intensive education on personal hygiene
Repeat hygiene methods for 5 days.

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	St. Louis	Missouri
United States	St. Louis Children's Hospital	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Eradicated of S. Aureus Carriage - 1 Month After Intervention	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	No
Secondary	Number of Participants With Recurrent Staphylococcus Aureus Skin or Soft Tissue Infection	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	No
Secondary	Number of Participants Eradicated of S. Aureus Carriage - 4 Months After Intervention	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	No