Clinical trial

Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection

Name
3177 60559
Description
The investigators propose a pragmatic comparative effectiveness trial evaluating several decolonization strategies in patients with Staphylococcus aureus infection, their household contacts, and household environmental surfaces. The central hypothesis of this proposal is that an integrated approach of periodic personal and household environmental hygiene will reduce S. aureus transmission in households and subsequently decrease the incidence of skin and soft tissue infections (SSTI).
Trial arms
Trial start
2015-10-01
Estimated PCD
2024-09-01
Trial end
2024-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Chlorhexidine
Arms:
Integrated personal/household hygiene, Periodic personal decolonization
Other names:
Hibiclens
Mupirocin
Arms:
Integrated personal/household hygiene, Periodic personal decolonization
Other names:
Bactroban
Household cleaning
Arms:
Household environmental hygiene, Integrated personal/household hygiene
Size
835
Primary endpoint
Incidence of SSTI
3 months after randomization
Eligibility criteria
Inclusion Criteria: * Patients 18 years of age and younger * Confirmed (i.e., culture-positive) active or recent (within the past 2 months) S. aureus cutaneous infections * Reside within 75 miles of St. Louis Children's Hospital * Provide written, informed consent, or consent is provided by a parent or legal guardian Exclusion Criteria: * Patients with nosocomial infections (i.e., \>48 hours after hospitalization) * Patients with traditional risk factors for HA-MRSA (e.g., immunodeficiency, indwelling catheter or percutaneous medical device, undergoing dialysis, presenting with a surgical site infection, or residing in a long-term care facility within the past year). * Patients who are unable to give consent or for whom consent is not obtained * Patients refusing home environmental cultures by the study team * Patients without a permanent home (e.g., living in a shelter or group home)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 835, 'type': 'ACTUAL'}}
Updated at
2024-05-23

1 organization

2 products

3 indications

Product
Mupirocin