Staphylococcus Aureus Decolonization Study

NCT ID: NCT00731783

Last Updated: 2012-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-12-31

Brief Summary

The purpose of this study is to determine whether measures to eliminate the Staph germ from the skin of the index patient (with a special ointment and soap) are more effective when performed by everyone in the household rather than the patient alone, and whether these methods are effective in preventing future Staph infections. The investigators hypothesize that there will be a greater number of households who are successful in eradicating the staph germ from the index patient when all members of the household participate than households where only the index patient is treated.

Detailed Description

Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).

CA-MRSA has become a major source of morbidity and mortality in our pediatric population. An important prerequisite for S. aureus infection may be nasal carriage of the organism. A variety of decolonization strategies have been used for infection prophylaxis, primarily in patients undergoing hemodialysis or surgery, with varying results. However, there are no published randomized eradication trials evaluating the decolonization and prevention of CA-MRSA infections in immunocompetent children in the outpatient setting. While the transmission of CA-MRSA within households has been reported, its contribution to recurrent CA-MRSA infection among household members is undetermined. The investigators hypothesize that spread of CA-MRSA among household members leads to recolonization or failure of decolonization in children undergoing eradication efforts.

Specific Aim: In pediatric patients presenting with a MRSA skin or soft tissue infection, compare the effectiveness of decolonization measures performed by an entire household in comparison to measures directed at the index patient alone. The investigators will conduct a randomized, controlled trial to test the hypothesis that decolonization measures performed by the entire household, specifically application of intranasal mupirocin ointment and bathing with chlorhexidine liquid soap, in addition to education and basic hygiene interventions, will be twice as effective in eradicating CA-MRSA carriage in the index patient than if the measures are performed only by the index patient.

Conditions

Staphylococcal Skin Infections; Abscesses; Furunculosis; Staphylococcus Aureus; MRSA Infection

Keywords

Abscesses; Furunculosis; Staphylococcus aureus colonization; Staphylococcal Skin Infections; MRSA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Index patient only

Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.

Group Type: ACTIVE_COMPARATOR

2% Mupirocin Ointment

Intervention Type: DRUG

Apply ointment to the anterior nares twice daily for 5 days.

4% Chlorhexidine liquid soap

Intervention Type: DRUG

Bathe with liquid soap daily for 5 days.

Hygiene protocol

Intervention Type: BEHAVIORAL

Follow key hygiene tips indefinitely. Tips are:

• Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
• Use liquid(pour or pump) soaps instead of bar soaps.
• Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
• Do not share personal care items such as razors and brushes.
• Wash all sheets and towels in hot water. Wash sheets every week.
• Use towels and wash cloths only once before washing and do not share.

Household

All members of the household (over the age of 6 months) will be asked to follow the study protocol.

Group Type: ACTIVE_COMPARATOR

2% Mupirocin Ointment

Intervention Type: DRUG

Apply ointment to the anterior nares twice daily for 5 days.

4% Chlorhexidine liquid soap

Intervention Type: DRUG

Bathe with liquid soap daily for 5 days.

Hygiene protocol

Intervention Type: BEHAVIORAL

Follow key hygiene tips indefinitely. Tips are:

• Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
• Use liquid(pour or pump) soaps instead of bar soaps.
• Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
• Do not share personal care items such as razors and brushes.
• Wash all sheets and towels in hot water. Wash sheets every week.
• Use towels and wash cloths only once before washing and do not share.

Interventions

2% Mupirocin Ointment

Apply ointment to the anterior nares twice daily for 5 days.

Intervention Type: DRUG

4% Chlorhexidine liquid soap

Bathe with liquid soap daily for 5 days.

Intervention Type: DRUG

Hygiene protocol

Follow key hygiene tips indefinitely. Tips are:

• Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
• Use liquid(pour or pump) soaps instead of bar soaps.
• Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
• Do not share personal care items such as razors and brushes.
• Wash all sheets and towels in hot water. Wash sheets every week.
• Use towels and wash cloths only once before washing and do not share.

Intervention Type: BEHAVIORAL

Other Intervention Names

Bactroban; Hibiclens

Eligibility Criteria

Inclusion Criteria

Screening:

• Children aged 6 months to 21 years presenting with an active skin or soft tissue infection.

Enrollment:

• Positive MRSA culture from the abscess and from either the axilla, anterior nares or groin area (signifying both infection and colonization with MRSA).

Exclusion Criteria

• Infants less than 6 months of age
• Dialysis or residence in a long term care facility over the past year
• Use of chlorhexidine or mupirocin in the past one month
• Pregnancy
• Immunodeficiency
• History of an adverse reaction to chlorhexidine or mupirocin.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Stephanie A. Fritz

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie A Fritz, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

St. Louis Children's Hospital

St Louis, Missouri, United States

Countries

United States

References

Fritz SA, Hogan PG, Hayek G, Eisenstein KA, Rodriguez M, Epplin EK, Garbutt J, Fraser VJ. Household versus individual approaches to eradication of community-associated Staphylococcus aureus in children: a randomized trial. Clin Infect Dis. 2012 Mar;54(6):743-51. doi: 10.1093/cid/cir919. Epub 2011 Dec 23.

Reference Type: DERIVED

PMID: 22198793 (View on PubMed)

Other Identifiers

3177 38145

Identifier Type: -

Identifier Source: org_study_id