Staphylococcus Aureus Clinical Trial
— HOME2DSOfficial title:
Individualized vs. Household Eradication of MRSA in Households With Children
Verified date | February 2019 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 474 |
Est. completion date | November 28, 2017 |
Est. primary completion date | February 26, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - 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." Exclusion Criteria: - Households in which all members experienced SSTI during the 12-month observational study - Individuals with known allergies to mupirocin or bleach (sodium hypochlorite) |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 3 months after enrollment | |
Secondary | 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 | 1 month after enrollment | |
Secondary | 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 | 6 months after enrollment | |
Secondary | 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 | 9 months after enrollment | |
Secondary | 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 | 12 months after enrollment | |
Secondary | Number of Participants Colonized With MRSA at 1 Month After Decolonization | Number of Participants Colonized with MRSA at the 1 Month longitudinal study visit | 1 month after enrollment | |
Secondary | Number of Participants Colonized With MRSA at 3 Months After Decolonization | Number of Participants Colonized with MRSA at the 3 Month longitudinal study visit | 3 months after enrollment | |
Secondary | Number of Participants Colonized With MRSA at 6 Months After Decolonization | Number of Participants Colonized with MRSA at the 6 Month longitudinal study visit | 6 months after enrollment | |
Secondary | Number of Participants Colonized With MRSA at 9 Months After Decolonization | Number of Participants Colonized with MRSA at the 9 Month longitudinal study visit | 9 months after enrollment | |
Secondary | Number of Participants Colonized With MRSA at 12 Months After Decolonization | Number of Participants Colonized with MRSA at the 12 Month longitudinal study visit | 12 months after enrollment | |
Secondary | 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. | 1 week after enrollment | |
Secondary | 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 | 1 month | |
Secondary | 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 | 1 month after enrollment | |
Secondary | 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. | 1 Year | |
Secondary | 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) | 1 week |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05073926 -
Rifampicin Resistance in S. Aureus During and After Treatment for Latent Tuberculosis
|
||
Completed |
NCT01212120 -
The Foot in Your Nose Study: Links Between Nasal Staphylococcus Aureus Colonies and Diabetic Foot Lesion Infections
|
N/A | |
Completed |
NCT00801879 -
Mupirocin Ointment to Eliminate Nasal Carriage of Staphylococcus Aureus in HIV Infection
|
Phase 4 | |
Terminated |
NCT03638947 -
Reducing Perioperative S. Aureus Transmission
|
N/A | |
Recruiting |
NCT05331885 -
A Human Monoclonal Antibody Against Staphylococcus Aureus Alpha Toxin in Mechanically Ventilated Adult Subjects - 2
|
Phase 3 | |
Recruiting |
NCT05094570 -
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
|
Phase 4 | |
Not yet recruiting |
NCT05092464 -
Exploratory Study to Evaluate the Application of NLAC Cream in Adults With Atopic Dermatitis
|
N/A | |
Recruiting |
NCT05695196 -
Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant
|
Phase 1 | |
Enrolling by invitation |
NCT04666532 -
S. Aureus Translocation From Skin and Nose to Periprosthetic Tissues
|
||
Active, not recruiting |
NCT02572791 -
Staph Household Intervention for Eradication (SHINE)
|
Phase 4 | |
Recruiting |
NCT04274348 -
Staphylococcal Toxins in Atopic Dermatitis and Eczema Herpeticum
|
N/A | |
Enrolling by invitation |
NCT05880069 -
Clinical Outcomes in Patients With Infection by Resistant Microorganism
|
||
Completed |
NCT01011335 -
Staphylococcus Aureus Toxoids Phase 1-2 Vaccine Trial
|
Phase 1/Phase 2 | |
Completed |
NCT03816956 -
Adjunctive Therapy to Antibiotics in the Treatment of S. Aureus Ventilator-Associated Pneumonia With AR-301
|
Phase 3 | |
Not yet recruiting |
NCT04884958 -
A Study to Investigate the Transmission and Burden of PVL-MRSA in Households in Sri Lanka
|
||
Completed |
NCT01105767 -
Methicillin-resistant Staphylococcus Aureus (MRSA) Skin and Soft Tissue Infection (SSTI) Prevention in Military Trainees
|
N/A | |
Completed |
NCT00475930 -
Chlorhexidine Impregnated Cloths to Prevent Skin and Soft Tissue Infections in Marine Officer Candidates
|
N/A | |
Completed |
NCT00507247 -
Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus
|
Phase 2 | |
Recruiting |
NCT03220386 -
Methicillin-sensitive and Methicillin-resistant Staphylococcus Aureus (MSSA/MRSA) - Point-of-care-testing (POCT) in Clinical Decision Making
|
N/A | |
Completed |
NCT03140423 -
Mupirocin-Iodophor ICU Decolonization Swap Out Trial
|
Phase 4 |