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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02572791
Other study ID # 3177 60559
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date October 2015
Est. completion date December 2024

Study information

Verified date May 2024
Source Washington University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

Patients with active or recent S. aureus SSTI will be recruited from St. Louis Children's Hospital and community pediatric practices affiliated with the investigators practice-based research network. All participants (index patients and their household contacts) will perform a baseline S. aureus decolonization protocol for 5 days consisting of enhanced hygiene measures, application of mupirocin antibiotic ointment to the anterior nares twice daily, and daily body washes with chlorhexidine antiseptic. Following the 5-day baseline decolonization regimen, households will be randomized to one of three intervention groups: 1) Periodic personal decolonization performed by all household members, to include chlorhexidine body washes twice weekly for 3 months and application of intranasal mupirocin for 5 consecutive days each month for 3 months; 2) Household environmental hygiene, including targeted cleaning of household surfaces and laundering of bed linens, weekly for 3 months; and 3) Integrated periodic personal decolonization and household environmental hygiene for 3 months. Households will be followed prospectively (1, 3, 6, and 9 months following randomization) to measure the prevalence of S. aureus colonization in the participants, household environmental surfaces, and pet dogs and cats and to document the incidence of recurrent SSTI. Molecular strain typing will be performed on all recovered S. aureus isolates to illuminate transmission dynamics and the effects of the decolonization measures on genetic epidemiology. Lastly, the investigators will assess resistance to the prescribed topical antimicrobials at baseline and longitudinal samplings.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 835
Est. completion date December 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Chlorhexidine

Mupirocin

Behavioral:
Household cleaning


Locations

Country Name City State
United States St. Louis Children's Hospital Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of SSTI We will compare the incidence of SSTI at the household level (i.e., occurring in any household member) 3 months after randomization between the 3 intervention groups. 3 months after randomization
Secondary Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces Describe baseline and longitudinal prevalence of MRSA colonization in index patients, household contacts, pet dogs and cats, and household surfaces and compare between the 3 intervention groups. 9 months (collected at baseline, 1 month, 3 months, 6 months, and 9 months).
Secondary Incidence of SSTI We will compare the incidence of SSTI at the household level (i.e., occurring in any household member) 1 month, 6 months, and 9 months after randomization between the 3 groups. 1 month, 6 months, and 9 months after randomization
Secondary Confirmed S. aureus Infection We will compare the development of a confirmed S. aureus infection between participants in the 3 groups over 9 months at the household and individual level. 9 months
Secondary Number of patients with adverse events due to study intervention We will describe the number of participants with adverse events due to study intervention (e.g., rhinorrhea, rash, dry skin) and compare between the three groups. 3 months
Secondary Mupirocin resistance Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months. 9 months
Secondary Number of participants adhering to study intervention procedures We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures. 3 months
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