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| Name | Class |
|---|---|
| Pennsylvania Department of Health | OTHER_GOV |
| Children's Hospital of Philadelphia | OTHER |
| Milton S. Hershey Medical Center | OTHER |
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The overall goal of this project is to elucidate the epidemiology of MRSA transmission in the community and test an intervention to prevent MRSA transmission in this setting.
The overall goals of this project are to:
to investigate the determinants of and evaluate potential interventions to reduce the spread of methicillin resistant Staphylococcus aureus (MRSA) infections in community settings in order to reduce the burden of this illness in the State of Pennsylvania. This objective has the following specific aims:
to foster multi-disciplinary and cross-institutional collaborations and develop the infrastructure for a Center of Excellence focused on antimicrobial drug resistance research, with the capacity for activities linking basic science, epidemiological and clinical intervention studies
to enhance opportunities for basic and clinical research training for undergraduate and graduate students, particularly from underrepresented minorities, in order to increase the pipeline of future biomedical scientists and clinical investigators
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unsupervised Decolonization | Experimental | Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. |
|
| Supervised Decolonization | Experimental | Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Study staff is in contact with household members during this intervention to ensure compliance. |
|
| No Intervention | No Intervention | Households do not undergo active MRSA decolonization protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unsupervised Decolonization | Drug | Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Infection | Confirmed new MRSA infections | Within 6 months |
| First Two Consecutive Sampling Periods Completed | Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis | Within 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization | Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture. | Within 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ebbing Lautenbach, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States | ||
| Children's Hospital of Philadelphia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28939607 | Derived | Shahbazian JH, Hahn PD, Ludwig S, Ferguson J, Baron P, Christ A, Spicer K, Tolomeo P, Torrie AM, Bilker WB, Cluzet VC, Hu B, Julian K, Nachamkin I, Rankin SC, Morris DO, Lautenbach E, Davis MF. Multidrug and Mupirocin Resistance in Environmental Methicillin-Resistant Staphylococcus aureus (MRSA) Isolates from Homes of People Diagnosed with Community-Onset MRSA Infection. Appl Environ Microbiol. 2017 Oct 31;83(22):e01369-17. doi: 10.1128/AEM.01369-17. Print 2017 Nov 15. | |
| 27465112 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unsupervised Decolonization | Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Supervised Decolonization | Drug | Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. In addition, households are contacted by study stuff via phone or text messages to ensure compliance, to provide reminders to household members to perform the decolonization protocol as well as to answer any question/concerns household members may have. |
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| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | United States |
| Derived |
| Cluzet VC, Gerber JS, Metlay JP, Nachamkin I, Zaoutis TE, Davis MF, Julian KG, Linkin DR, Coffin SE, Margolis DJ, Hollander JE, Bilker WB, Han X, Mistry RD, Gavin LJ, Tolomeo P, Wise JA, Wheeler MK, Hu B, Fishman NO, Royer D, Lautenbach E; CDC Prevention Epicenters Program. The Effect of Total Household Decolonization on Clearance of Colonization With Methicillin-Resistant Staphylococcus aureus. Infect Control Hosp Epidemiol. 2016 Oct;37(10):1226-33. doi: 10.1017/ice.2016.138. Epub 2016 Jul 28. |
| FG001 | Supervised Decolonization | Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns. |
| FG002 | No Intervention | Households do not undergo active MRSA decolonization protocol |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Unsupervised Decolonization | This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the "no intervention" group. |
| BG001 | Supervised Decolonization | This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview. |
| BG002 | No Intervention | Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages). |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent Infection | Confirmed new MRSA infections | These study participants who self-reported re-infections of MRSA | Posted | Number | participants | Within 6 months |
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| Primary | First Two Consecutive Sampling Periods Completed | Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis | These subjects sent in two consecutive swab samples starting with their first follow-up time point. | Posted | Number | participants | Within 2 months |
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| Secondary | Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization | Surveillance cultures negative for two consecutive sampling periods; date of clearance determined as midpoint between date of last positive surveillance culture and first negative surveillance culture. | Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis, as this was necessary to determine clearance of MRSA colonization | Posted | Median | 95% Confidence Interval | days | Within 6 months |
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1 week
Serious adverse events include:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Unsupervised Decolonization | Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member. | 5 | 76 | 17 | 76 | ||
| EG001 | Supervised Decolonization | Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members. Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns. | 7 | 74 | 29 | 74 | ||
| EG002 | No Intervention | Households do not undergo active MRSA decolonization protocol | 4 | 73 | 0 | 73 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart disease | Cardiac disorders | Systematic Assessment | This adverse event was both unrelated and unanticipated; participants had multiple chronic conditions including: CHF, PE, infarction, Afib, DM with neuropathy, HTN, CKD, Cutaneous lymphoma; inpatient hospice. |
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| Anorexia nervosa | Metabolism and nutrition disorders | Non-systematic Assessment |
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| homocide | Injury, poisoning and procedural complications | Systematic Assessment |
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| inflammatory bowel | Metabolism and nutrition disorders | Non-systematic Assessment |
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| cancer | Reproductive system and breast disorders | Systematic Assessment |
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| hypertension | Cardiac disorders | Systematic Assessment |
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| cancer | Blood and lymphatic system disorders | Systematic Assessment |
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| hemmorage | Gastrointestinal disorders | Systematic Assessment |
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| abscess | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| runny nose | General disorders | Non-systematic Assessment | subject reported a drippy nose |
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| abscess | Infections and infestations | Non-systematic Assessment |
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| burning | Skin and subcutaneous tissue disorders | Non-systematic Assessment | burning feeling on the skin |
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| Broken bone | Injury, poisoning and procedural complications | Non-systematic Assessment | broken ankle |
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| feel sick | General disorders | Systematic Assessment | subject reported feeling ill |
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| nasal congestion | General disorders | Systematic Assessment |
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| headache | General disorders | Systematic Assessment |
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| sore throat | General disorders | Systematic Assessment |
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| common cold | General disorders | Systematic Assessment |
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| fever | Infections and infestations | Systematic Assessment |
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| flu | Infections and infestations | Systematic Assessment |
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| itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| sneezing | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ebbing Lautenbach, MD, MPH, MSCE | Perelman School of Medicine, University of Pennsylvania | 215-898-6977 | ebbing@mail.med.upenn.edu |
| ID | Term |
|---|---|
| D007239 | Infections |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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