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

Sponsor:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00513799

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Germs and Hygiene Skin Infections

Drug Information available for: Chlorhexidine Mupirocin Chlorhexidine digluconate Hibiclens Mupirocin calcium

U.S. FDA Resources

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

Primary Outcome Measures:

Decolonization of Staphylococcus aureus [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Prevention of recurrent Staphylococcus aureus skin or soft tissue infection [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	March 2007
Estimated Study Completion Date:	January 2010
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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.
2: Active Comparator 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. Behavioral: Intensive education on personal hygiene Repeat hygiene methods for 5 days.
3: Active Comparator 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. Procedure: Chlorhexidine showers Apply Clorhexidine wash to entire body once daily for 5 days. Behavioral: Intensive education on personal hygiene Repeat hygiene methods for 5 days.
4: Active Comparator 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. 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.

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

Responsible Party:	Washington University School of Medicine ( Bernard Camins, MD )
Study ID Numbers:	9000C4
Study First Received:	August 8, 2007
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00513799 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Disinfectants
Bacterial Infections
Anti-Infective Agents
Communicable Diseases
Chlorhexidine
Mupirocin
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Furunculosis
Enzyme Inhibitors
Staphylococcal Skin Infections

Infection
Pharmacologic Actions
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Staphylococcal Infections
Anti-Infective Agents, Local
Skin Diseases, Infectious
Gram-Positive Bacterial Infections
Therapeutic Uses
Skin Diseases, Bacterial

ClinicalTrials.gov processed this record on February 08, 2010