N/A
N=183
Staphylococcus Aureus Decolonization Study
Staphylococcal Skin Infections · Abscesses · Furunculosis · Staphylococcus Aureus · MRSA Infection
Bottom Line
View on ClinicalTrials.gov: NCT00731783 ↗Enrolled (actual)
183
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures — 39; 35 Participants — p=1.00
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 2% Mupirocin Ointment (Drug); 4% Chlorhexidine liquid soap (Drug); Hygiene protocol (Behavioral)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Index Patients Eradicated of S. Aureus Carriage - 1 Month After Performing Decolonization Measures |
39; 35 | 1.00 |
| SECONDARY Number of Index Patients Eradicated of S. Aureus Carriage - 3 Month After Performing Decolonization Measures |
39; 41 | 0.05 |
| SECONDARY Number of Index Patients Eradicated of S. Aureus Carriage - 6 Month After Performing Decolonization Measures |
39; 31 | 0.49 |
| SECONDARY Number of Index Patients Eradicated of S. Aureus Carriage - 12 Month After Performing Decolonization Measures |
37; 38 | 0.28 |
| SECONDARY Recurrence of CA-MRSA Skin or Soft Tissue Infection - 1 Month After Enrollment. |
21; 11 | 0.12 |
| SECONDARY Recurrence of CA-MRSA Skin or Soft Tissue Infection - 3 Month After Enrollment. |
36; 19 | 0.02 sig |
| SECONDARY Recurrence of CA-MRSA Skin or Soft Tissue Infection - 6 Month After Enrollment. |
46; 26 | 0.008 sig |
| SECONDARY Recurrence of CA-MRSA Skin or Soft Tissue Infection - 12 Month After Enrollment. |
56; 34 | 0.02 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00731783). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.