Skin and Subcutaneous Tissue Bacterial Infections, Staphylococcus Aureus, MRSA - Methicillin Resistant Staphylococcus Aureus Infection
Conditions
Brief 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).
Detailed 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.
Interventions
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Households With at Least One Skin and Soft Tissue Infection | 3 months after randomization | Number of households with at least one SSTI between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of MRSA Colonization in Participants | Baseline sampling | Describe baseline prevalence of MRSA colonization in participants |
| Confirmed S. Aureus Infection | 9 months | 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. |
| Incidence of SSTI | 1 month | We will compare the number of households in which at least one household member develops SSTI 1 month after randomization between the Integrated Decolonization Group and the combined Personal Periodic Decolonization and Environmental Decontamination Groups. |
| Mupirocin Resistance | 9 months | Measure the prevalence of mupirocin resistance in S. aureus strains recovered at serial samplings over the study period of 9 months. |
| Number of Patients With Adverse Events Due to Study Intervention | 3 months | 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. |
| Number of Participants Adhering to Study Intervention Procedures | 3 months | We will describe the number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures. |
| SSTI Incidence: Participants With SSTI in the Year Prior to Trial Enrollment | 1 Month | Incidence of SSTI in Participants who Experienced an SSTI in the Year Prior to Enrollment. During the enrollment survey, all participants were asked if they had ever had an SSTI, and when the SSTI occurred. If a participant had experienced an SSTI before joining this study, and that SSTI occurred less than a year before their enrollment date, they were included in this subgroup. |
| SSTI Incidence: Individual Level | 1 Month | Individual Participant SSTI Incidence |
| SSTI Incidence: Index Patients | 1 Month | Cumulative Incidence of SSTI in Index Patients |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStephanie A Fritz, MD, MSCI
Washington University School of Medicine
Participant flow
Recruitment details
From 2015-2021, pediatric patients with culture-confirmed, community-onset S. aureus SSTIs ("index patients") were recruited from St. Louis Children's Hospital (SLCH) and community pediatric practices in metropolitan St. Louis. Children with nosocomial infections, healthcare-related risk factors, or immunodeficiency were excluded. Household contacts (individuals sleeping in the home ≥4 nights per week) were also enrolled. All study visits were conducted in participants' homes.
Pre-assignment details
After the enrollment visit, all study participants (index patients and household contacts) were asked to perform a 5-day baseline decolonization regimen consisting of twice-daily application of 2% mupirocin ointment (Perrigo, Allegan, MI) to the anterior nares, and daily body washes with 4% chlorhexidine gluconate (Hibiclens, Mölnlycke Health Care, Norcross, GA).5,12,13,21,22 Participants \<2 months of age were excluded from performing the decolonization regimen.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 17 Years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 818 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 17 Participants |
| Race (NIH/OMB) Black or African American | 83 Participants |
| Race (NIH/OMB) More than one race | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 533 Participants |
| Region of Enrollment United States | 270 participants |
| Sex: Female, Male Female | 469 Participants |
| Sex: Female, Male Male | 115 Participants |
| Skin Infection in the Year Prior to Study Enrollment | 80 number of participants w/skin infections |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 274 | 0 / 269 | 0 / 292 |
| other Total, other adverse events | 111 / 274 | 93 / 269 | 137 / 292 |
| serious Total, serious adverse events | 0 / 274 | 0 / 269 | 0 / 292 |
Outcome results
None listed