N/A N=474 Randomized Prevention

Individualized vs. Household MRSA Decolonization

Staphylococcal Skin Infection · Abscess · Furunculosis · Staphylococcus Aureus · MRSA Infection

Bottom Line

View on ClinicalTrials.gov: NCT01814371 ↗

Enrolled (actual)

474

Serious AEs

0.0%

Results posted

Oct 2018

Primary outcome: Primary: Number of Participants With Incidence of SSTI at 3 Months After Decolonization — 23; 23 Participants — p=0.757

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 2% mupirocin ointment (Drug); Bleach Bath (dilute) (Other); Hygiene Protocol (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Washington University School of Medicine
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Incidence of SSTI at 3 Months After Decolonization	23; 23	0.757
SECONDARY Number of Participants With Incidence of SSTI at 1 Month After Decolonization	8; 8	1.00
SECONDARY Number of Participants With Incidence of SSTI at 6 Months After Decolonization	32; 33	0.687
SECONDARY Number of Participants With Incidence of SSTI at 9 Months After Decolonization	39; 35	1.00
SECONDARY Number of Participants With Incidence of SSTI at 12 Months After Decolonization	48; 41	0.811
SECONDARY Number of Participants Colonized With MRSA at 1 Month After Decolonization	45; 20	0.004 sig
SECONDARY Number of Participants Colonized With MRSA at 3 Months After Decolonization	51; 26	0.006 sig
SECONDARY Number of Participants Colonized With MRSA at 6 Months After Decolonization	39; 21	0.050
SECONDARY Number of Participants Colonized With MRSA at 9 Months After Decolonization	40; 17	0.007 sig
SECONDARY Number of Participants Colonized With MRSA at 12 Months After Decolonization	47; 22	0.005 sig
SECONDARY Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period	41; 102	1.00
SECONDARY Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance	31; 20	0.84
SECONDARY Number of Participants Incurring Economic Burden of Performing Protocol	75	—
SECONDARY Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.	14; 8	0.381
SECONDARY Number of Participants Adhering to Decolonization Measures	61; 130	0.143

Summary

The purpose of this research study is to compare the effectiveness of commonly used decolonization treatments (application of mupirocin antibiotic ointment to the nose and bleach baths) when performed by individuals with a history of skin and soft tissue infection (SSTI) in the prior year (individualized approach) in comparison to decolonization of all household members (household approach) in an attempt to prevent Staphylococcus aureus skin infections. The investigators hypothesize an individualized decolonization approach will be equally as effective as a household approach to prevent SSTI.

Eligibility Criteria

Inclusion Criteria

Individuals who are enrolled in a 12-month observational study entitled "The Community-Associated Methicillin-Resistant Staphylococcus aureus Among Household Members and the Home Environment Study."

Exclusion Criteria

Households in which all members experienced SSTI during the 12-month observational study
Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01814371). 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.