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Staph Household Intervention for Eradication (SHINE) (SHINE)

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ClinicalTrials.gov Identifier: NCT02572791
Recruitment Status : Recruiting
First Posted : October 9, 2015
Last Update Posted : July 2, 2020
Sponsor:
Information provided by (Responsible Party):
Stephanie A. Fritz, Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Skin and Subcutaneous Tissue Bacterial Infections Staphylococcus Aureus MRSA - Methicillin Resistant Staphylococcus Aureus Infection Drug: Chlorhexidine Drug: Mupirocin Behavioral: Household cleaning Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrating Personal and Household Environmental Hygiene Measures to Prevent Methicillin-Resistant Staphylococcus Aureus Infection
Study Start Date : October 2015
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : February 2022


Arm Intervention/treatment
Experimental: Periodic personal decolonization
All household participants will perform chlorhexidine body washes twice weekly for 3 months and apply mupirocin ointment to the anterior nares twice daily for five consecutive days each month for 3 months.
Drug: Chlorhexidine
Other Name: Hibiclens

Drug: Mupirocin
Other Name: Bactroban

Experimental: Household environmental hygiene
In addition to their usual cleaning, households will be asked to perform targeted household hygiene focusing on sources known to harbor S. aureus and serve as reservoirs for transmission.
Behavioral: Household cleaning
Experimental: Integrated personal/household hygiene
Participants in households randomized to this arm will perform the Periodic Personal Decolonization plus the Household Environmental Hygiene, described above in arms 1 and 2.
Drug: Chlorhexidine
Other Name: Hibiclens

Drug: Mupirocin
Other Name: Bactroban

Behavioral: Household cleaning



Primary Outcome Measures :
  1. Incidence of SSTI [ Time Frame: 3 months after randomization ]
    Incidence of SSTI at the household level (i.e., occurring in any household member) 3 months after randomization.


Secondary Outcome Measures :
  1. Prevalence of S. aureus colonization in index patients, household contacts, pet dogs and cats, and household surfaces [ Time Frame: 9 months (collected at baseline, 1 month, 3 months, 6 months, and 9 months). ]
    • Baseline and longitudinal prevalence of MRSA colonization in index patients, household contacts, pet dogs and cats, and household surfaces, and the molecular characterization (i.e., strain type) and relatedness of these recovered strains.

  2. Incidence of SSTI [ Time Frame: 1 month, 6 months, and 9 months after randomization ]
    Incidence of SSTI at the household level (i.e., occurring in any household member) 1 month, 6 months, and 9 months after randomization. And at the individual level at 1 month, 3 months, 6 months, and 9 months after randomization.

  3. Confirmed S. aureus Infection [ Time Frame: 9 months ]
    Development of a confirmed S. aureus infection over 9 months at the household and individual level

  4. S. aureus transmission [ Time Frame: 9 months ]
    S. aureus transmission within households over 9 months as determined by molecular strain typing.

  5. Number of patients with adverse events due to study intervention [ Time Frame: 3 months ]
    Number of patients with adverse events due to study intervention (e.g., rhinorrhea, rash, dry skin)

  6. Mupirocin and chlorhexidine resistance [ Time Frame: 9 months ]
    Mupirocin and chlorhexidine resistance in S. aureus strains recovered at serial samplings over the study period of 9 months.

  7. Number of participants adhering to study intervention procedures [ Time Frame: 3 months ]
    Number of participants completing chlorhexidine baths, mupirocin applications, and household hygiene measures



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572791


Contacts
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Contact: Stephanie A Fritz, MD, MSCI 314 454 4115 fritz.s@wustl.edu
Contact: Patrick G Hogan, MPH 314 747 6296 pghogan@wustl.edu

Locations
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United States, Missouri
St. Louis Children's Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Stephanie A Fritz, MD    314-454-6050    Fritz.S@wustl.edu   
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Principal Investigator: Stephanie A Fritz, MD, MSCI         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Stephanie A Fritz, MD, MSCI Washington University School of Medicine
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Responsible Party: Stephanie A. Fritz, Associate Professor of Pediatrics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02572791    
Other Study ID Numbers: 3177 60559
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: July 2, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Staphylococcal Infections
Gram-Positive Bacterial Infections
Chlorhexidine
Chlorhexidine gluconate
Mupirocin
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action