Staphylococcal Skin InfectionHOME2DSNCT01814371
Individualized vs. Household MRSA Decolonization
A study testing 2% mupirocin ointment, Bleach Bath (dilute) and Hygiene Protocol in people with Staphylococcal Skin Infection and Abscess, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Staphylococcal Skin Infection, Abscess, Furunculosis
- What is being tested?
- 2% mupirocin ointment, Bleach Bath (dilute) and Hygiene Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 28 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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."
Who cannot join
- Households in which all members experienced SSTI during the 12-month observational study
- Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Individualized vs. Household Eradication of MRSA in Households With Children
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.
Read the detailed description
Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).
There is no available vaccine against S. aureus. Thus, other preventive measures, including topical antimicrobial therapies, have been used in an attempt to prevent staphylococcal infections. These therapies include mupirocin (a topical antibiotic with activity against MRSA) and dilute bleach water baths. The effectiveness of these measures directed at patients colonized with traditional MSSA and HA-MRSA strains in an attempt to prevent nosocomial infections varies across studies, and maintenance of eradication diminishes over time. With the emergence of the CA-MRSA epidemic, these measures have been extrapolated to patients in community settings. We aim to find a practical approach to decolonization which patients can feasibly perform at home to reduce the incidence of skin and soft tissue infections(SSTI).
Specific Aim: Compare the effectiveness of decolonization of individuals with a history of SSTI in the prior year (individualized approach) to decolonization of all household members (household approach) in reducing the incidence of recurrent SSTI. Primary hypothesis: An individualized decolonization approach will be equally as effective as decolonization of all household members to prevent SSTI. Secondary hypothesis: Application of mupirocin to the anterior nares twice daily for 5 days will not result in a higher prevalence of colonization with mupirocin-resistant strains at subsequent longitudinal samplings.
- Conditions
- Staphylococcal Skin Infection, Abscess, Furunculosis, Staphylococcus Aureus, MRSA Infection
- Being tested
- 2% mupirocin ointment, Bleach Bath (dilute), Hygiene Protocol
- Keywords
- Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infection, MRSA
- Medical subject headings
- Staphylococcal Skin Infections, Abscess, Furunculosis, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% mupirocin ointmentDrug
Also called Bactroban
Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.
Bleach Bath (dilute)Other
Also called Clorox
Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.
Hygiene ProtocolBehavioural
Follow key hygiene tips:
- Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
- Use liquid(pour or pump) soaps instead of bar soaps.
- Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
- Do not share personal care items such as razors, brushes, or deodorant.
- Wash all sheets and towels in hot water. Wash sheets every week.
- Use towels and wash cloths only once before washing and do not share.
| Study group | Role | What they receive |
|---|---|---|
| Individualized Approach | Active comparator | The decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. Receives: Drug: 2% mupirocin ointment; Other: Bleach Bath (dilute); Behavioral: Hygiene Protocol |
| Household Approach | Active comparator | All members of the household will perform the decolonization regimen. Receives: Drug: 2% mupirocin ointment; Other: Bleach Bath (dilute); Behavioral: Hygiene Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Incidence of SSTI at 3 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol
Measured: 3 months after enrollment
Secondary outcomes (14)
Number of Participants With Incidence of SSTI at 1 Month After Decolonization
Cumulative Number of Participants with SSTI at any time during the 1 Month following Decolonization protocol
Measured: 1 month after enrollment
Number of Participants With Incidence of SSTI at 6 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 6 Months following Decolonization protocol
Measured: 6 months after enrollment
Number of Participants With Incidence of SSTI at 9 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 9 Months following Decolonization protocol
Measured: 9 months after enrollment
Number of Participants With Incidence of SSTI at 12 Months After Decolonization
Cumulative Number of Participants with SSTI at any time during the 12 Months following Decolonization protocol
Measured: 12 months after enrollment
Number of Participants Colonized With MRSA at 1 Month After Decolonization
Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit
Measured: 1 month after enrollment
Number of Participants Colonized With MRSA at 3 Months After Decolonization
Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit
Measured: 3 months after enrollment
Number of Participants Colonized With MRSA at 6 Months After Decolonization
Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit
Measured: 6 months after enrollment
Number of Participants Colonized With MRSA at 9 Months After Decolonization
Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit
Measured: 9 months after enrollment
Number of Participants Colonized With MRSA at 12 Months After Decolonization
Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit
Measured: 12 months after enrollment
Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period
Number of participants who report development of Nasal burning, itching, stinging, or runny nose or Skin itching, dry skin, or rash during the decolonization period.
Measured: 1 week after enrollment
Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance
Number of all recovered S. aureus isolates resistant to mupirocin at the study visit before decolonization protocol and the study visit immediately after decolonization protocol
Measured: 1 month
Number of Participants Incurring Economic Burden of Performing Protocol
Number of participants incurring additional costs during their compliance with prescribed hygiene measures prescribed with the decolonization regimen: e.g., cost of containers of lotion or bars of soap discarded, cost of new pump or pour lotion or soap purchased, cost of new personal hygiene items or linens, cost of additional loads of laundry
Measured: 1 month after enrollment
Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.
Number of participants reporting the development of a MRSA infection over the year of longitudinal follow-up that has been culture- and physician-confirmed through verification by medical record and culture report.
Measured: 1 Year
Number of Participants Adhering to Decolonization Measures
Number of participants Adhering to decolonization measures. Defined as reported completion of at least 4 of the 5 assigned days (8 or more mupirocin applications and 4 or more bleach baths)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2013 (estimated)
- Study startApr 2013
- Primary completion26 Feb 2017
- Study completion28 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Staphylococcal Skin InfectionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie A. Fritz, Washington University School of Medicine
- Investigators
- Stephanie A Fritz, MD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814371
- Sponsor's protocol ID
- R01HS021736
- Acronym
- HOME2DS
- Status last verified
- Feb 2019
- First submitted
- 15 Mar 2013
- Last updated
- 21 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hogan PG, Parrish KL, Mork RL, Boyle MG, Muenks CE, Thompson RM, Morelli JJ, Sullivan ML, Hunstad DA, Bubeck Wardenburg J, Rzhetsky A, Gehlert SJ, Burnham CD, Fritz SA. HOME2 Study: Household Versus Personalized Decolonization in Households of Children With Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection-A Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 6;73(11):e4568-e4577. doi: 10.1093/cid/ciaa752.
PubMed 32521007
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized vs. Household Eradication of MRSA in Households With Children
- ClinicalTrials.gov ID
- NCT01814371
- Acronym / sponsor ID
- HOME2DS / R01HS021736
- Conditions
- Staphylococcal Skin Infection, Abscess, Furunculosis, Staphylococcus Aureus, MRSA Infection
- Keywords
- Abscesses, Furunculosis, Staphylococcus aureus colonization, Staphylococcal Skin Infection, MRSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 474 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 26 Feb 2017 (actual)
- Study completion
- 28 Nov 2017 (actual)
- First posted
- 19 Mar 2013 (estimated)
- Results
- Posted 26 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Methicillin-resistant Staphylococcus aureus (MRSA) was once uniformly associated with hospital-acquired infections; however, MRSA strains have emerged that thrive outside the hospital environment, causing significant morbidity and mortality among immunocompetent individuals, leading to their designation as community-acquired methicillin resistant Staphylococcus aureus (CA-MRSA).
There is no available vaccine against S. aureus. Thus, other preventive measures, including topical antimicrobial therapies, have been used in an attempt to prevent staphylococcal infections. These therapies include mupirocin (a topical antibiotic with activity against MRSA) and dilute bleach water baths. The effectiveness of these measures directed at patients colonized with traditional MSSA and HA-MRSA strains in an attempt to prevent nosocomial infections varies across studies, and maintenance of eradication diminishes over time. With the emergence of the CA-MRSA epidemic, these measures have been extrapolated to patients in community settings. We aim to find a practical approach to decolonization which patients can feasibly perform at home to reduce the incidence of skin and soft tissue infections(SSTI).
Specific Aim: Compare the effectiveness of decolonization of individuals with a history of SSTI in the prior year (individualized approach) to decolonization of all household members (household approach) in reducing the incidence of recurrent SSTI. Primary hypothesis: An individualized decolonization approach will be equally as effective as decolonization of all household members to prevent SSTI. Secondary hypothesis: Application of mupirocin to the anterior nares twice daily for 5 days will not result in a higher prevalence of colonization with mupirocin-resistant strains at subsequent longitudinal samplings.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Approach | Active comparator | Drug: 2% mupirocin ointment, Other: Bleach Bath (dilute), Behavioral: Hygiene ProtocolThe decolonization regimen will be performed only by those household members who experienced SSTI in the prior year. |
| Household Approach | Active comparator | Drug: 2% mupirocin ointment, Other: Bleach Bath (dilute), Behavioral: Hygiene ProtocolAll members of the household will perform the decolonization regimen. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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."
Key exclusion criteria (2 listed)
- Households in which all members experienced SSTI during the 12-month observational study
- Individuals with known allergies to mupirocin or bleach (sodium hypochlorite)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2% mupirocin ointmentAlso: BactrobanParticipants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days. | Drug | Household Approach, Individualized Approach |
| Bleach Bath (dilute)Also: CloroxParticipants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days. | Other | Household Approach, Individualized Approach |
| Hygiene ProtocolFollow key hygiene tips: * Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles. * Use liquid(pour or pump) soaps instead of bar soaps. * Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell. * Do not share personal care items such as razors, brushes, or deodorant. * Wash all sheets and towels in hot water. Wash sheets every week. * Use towels and wash cloths only once before washing and do not share. | Behavioural | Household Approach, Individualized Approach |
Primary outcome
Number of Participants With Incidence of SSTI at 3 Months After Decolonization
Time frame: 3 months after enrollment
Cumulative Number of Participants with SSTI at any time during the 3 Months following Decolonization protocol
14 secondary outcomes
Number of Participants With Incidence of SSTI at 1 Month After Decolonization
Time frame: 1 month after enrollment
Number of Participants With Incidence of SSTI at 6 Months After Decolonization
Time frame: 6 months after enrollment
Number of Participants With Incidence of SSTI at 9 Months After Decolonization
Time frame: 9 months after enrollment
Number of Participants With Incidence of SSTI at 12 Months After Decolonization
Time frame: 12 months after enrollment
Number of Participants Colonized With MRSA at 1 Month After Decolonization
Time frame: 1 month after enrollment
Number of Participants Colonized With MRSA at 3 Months After Decolonization
Time frame: 3 months after enrollment
Number of Participants Colonized With MRSA at 6 Months After Decolonization
Time frame: 6 months after enrollment
Number of Participants Colonized With MRSA at 9 Months After Decolonization
Time frame: 9 months after enrollment
Number of Participants Colonized With MRSA at 12 Months After Decolonization
Time frame: 12 months after enrollment
Number of Participants Who Report Development of Adverse Effects Occurring During Decolonization Period
Time frame: 1 week after enrollment
Number of All Recovered S. Aureus Isolates With High-level Mupirocin Resistance
Time frame: 1 month
Number of Participants Incurring Economic Burden of Performing Protocol
Time frame: 1 month after enrollment
Number of Participants Reporting a Confirmed MRSA Infection Over the 12-month Longitudinal Study Period.
Time frame: 1 Year
Number of Participants Adhering to Decolonization Measures
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32521007Hogan PG, Parrish KL, Mork RL, Boyle MG, Muenks CE, Thompson RM, Morelli JJ, Sullivan ML, Hunstad DA, Bubeck Wardenburg J, Rzhetsky A, Gehlert SJ, Burnham CD, Fritz SA. HOME2 Study: Household Versus Personalized Decolonization in Households of Children With Methicillin-Resistant Staphylococcus aureus Skin and Soft Tissue Infection-A Randomized Clinical Trial. Clin Infect Dis. 2021 Dec 6;73(11):e4568-e4577. doi: 10.1093/cid/ciaa752.
Related trials for Staphylococcal Skin Infection
Recruiting
Perspectives on Antibiotics and Tracking Symptoms in Children
Urinary Tract Infection, Cellulitis
Recruiting
Retention of Vernix Caseosa in Newborns for Primary Prevention of Atopic Dermatitis
Atopic Dermatitis
Not yet recruitingObservational study
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Atopic Dermatitis (AD), Scabies
Not yet recruitingObservational study
Intertriginous/Periorificial Dermatoses in Patients With IBD on Anti-TNFα: Relative Abundance of Staphylococcus Aureus Within the Lesion Microbiota and Clinical Correlation (micSPIDER).
Inflammatory Bowel Diseases, Crohn's Disease
Not yet recruitingObservational study
Comparative Study of Adherence to Antibiotic Therapy Among Pediatric Patients: Hospital Emergency Department vs. Primary Care Center
Tonsillitis Acute, Pneumonia - Bacterial
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephanie A Fritz, MD, MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2% mupirocin ointment, Bleach Bath (dilute) and Hygiene Protocol in people with Staphylococcal Skin Infection and Abscess, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Incidence of SSTI at 3 Months After Decolonization (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01814371, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.