Staphylococcus Aureus Decolonization Study (SuDS)

• ClinicalTrials.gov Identifier: NCT00731783
• Recruitment Status: Completed
• First Posted: August 11, 2008
• Results First Posted: March 23, 2011
• Last Update Posted: April 30, 2012
• Sponsor: Washington University School of Medicine
• Information provided by (Responsible Party): Stephanie A. Fritz, Washington University School of Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Staphylococcal Skin Infections; Abscesses; Furunculosis; Staphylococcus Aureus; MRSA Infection	Drug: 2% Mupirocin Ointment; Drug: 4% Chlorhexidine liquid soap; Behavioral: Hygiene protocol	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 183 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Household vs. Individual Approach to Decolonization of Community-acquired Methicillin-resistant Staphylococcus Aureus.
• Study Start Date: July 2008
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: December 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Index patient only; Only the child recently treated for a skin or soft tissue infection will undergo the decolonization regimen.	Drug: 2% Mupirocin Ointment; Apply ointment to the anterior nares twice daily for 5 days.; Other Name: Bactroban; Drug: 4% Chlorhexidine liquid soap; Bathe with liquid soap daily for 5 days.; Other Name: Hibiclens; Behavioral: 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.
Active Comparator: Household; All members of the household (over the age of 6 months) will be asked to follow the study protocol.	Drug: 2% Mupirocin Ointment; Apply ointment to the anterior nares twice daily for 5 days.; Other Name: Bactroban; Drug: 4% Chlorhexidine liquid soap; Bathe with liquid soap daily for 5 days.; Other Name: Hibiclens; Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures [ Time Frame: 1 month after enrollment. ]
   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.

Secondary Outcome Measures :

1. Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures [ Time Frame: 3 month after enrollment. ]
   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.
2. Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures [ Time Frame: 6 month after enrollment. ]
   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.
3. Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures [ Time Frame: 12 month after enrollment. ]
   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.
4. Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment. [ Time Frame: 1 month after enrollment ]
   Recurrence of CA-MRSA Skin or Soft Tissue Infection
5. Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment. [ Time Frame: 3 month after enrollment ]
   Recurrence of CA-MRSA Skin or Soft Tissue Infection
6. Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment. [ Time Frame: 6 month after enrollment ]
   Recurrence of CA-MRSA Skin or Soft Tissue Infection
7. Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment. [ Time Frame: 12 month after enrollment ]
   Recurrence of CA-MRSA Skin or Soft Tissue Infection

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Missouri

St. Louis Children's Hospital

St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Investigators

• Principal Investigator: Stephanie A Fritz, MD; Washington University School of Medicine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Stephanie A. Fritz, Assistant Professor of Pediatrics, Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT00731783
• Other Study ID Numbers: 3177 38145
• First Posted: August 11, 2008
• Results First Posted: March 23, 2011
• Last Update Posted: April 30, 2012
• Last Verified: April 2012

Keywords provided by Stephanie A. Fritz, Washington University School of Medicine:

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

Additional relevant MeSH terms:

Infections; Communicable Diseases; Staphylococcal Infections; Abscess; Cellulitis; Skin Diseases, Infectious; Staphylococcal Skin Infections; Furunculosis; Disease Attributes; Pathologic Processes; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Suppuration; Inflammation; Connective Tissue Diseases; Skin Diseases; Skin Diseases, Bacterial; Chlorhexidine; Chlorhexidine gluconate; Mupirocin; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Dermatologic Agents; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action