MRSA - Methicillin Resistant Staphylococcus Aureus InfectionNCT00966446
Epidemiology and Prevention of Methicillin Resistant Staphylococcus Aureus (MRSA) Transmission in the Community
A study testing Unsupervised Decolonization and Supervised Decolonization in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection, run by University of Pennsylvania at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- MRSA - Methicillin Resistant Staphylococcus Aureus Infection
- What is being tested?
- Unsupervised Decolonization and Supervised Decolonization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2009to Dec 2014
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All members of a household in which the index case is treated for a skin or soft tissue infection due to MRSA. All household members must agree to participate in order for the household to be enrolled
Who cannot join
- Prior MRSA within past 6 months in the index case; age less than 6 months.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Hershey Medical Center
Hershey, Pennsylvania, 17033
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Epidemiology and Prevention of MRSA Transmission in the Community
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.
Read the detailed description
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 identify host, microbiological and environmental risk factors for prolonged MRSA colonization, MRSA transmission and clinical MRSA infection among patients with MRSA skin and soft tissue infections (SSTIs) and their household contacts and to use stochastic agent-based modeling methods to quantify secondary spread of CO-MRSA in households.
- to evaluate the impact of a decolonization intervention on MRSA infections in the household.
- to identify immunological mechanisms underlying the ability of Streptococcus pneumoniae colonization to inhibit MRSA colonization, transmission and infection in order to identify potential future immunological targets for interventions.
- 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
- Being tested
- Unsupervised Decolonization, Supervised Decolonization
- Keywords
- MRSA; household; infection; colonization
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unsupervised DecolonizationDrug
Also called Experimental: 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.
Supervised DecolonizationDrug
Also called Experimental: Supervised 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. 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Unsupervised Decolonization |
| 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. Receives: Drug: Supervised Decolonization |
| No Intervention | No intervention | Households do not undergo active MRSA decolonization protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Infection
Confirmed new MRSA infections
Measured: 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
Measured: Within 2 months
Secondary outcomes (1)
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.
Measured: Within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2014
- Study completionDec 2014
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 (2)Papers the sponsor has linked to this study.
- Other trials for MRSA - Methicillin Resistant Staphylococcus Aureus InfectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health, Children's Hospital of Philadelphia, Milton S. Hershey Medical Center
- Responsible party
- Sponsor
- Investigators
- Ebbing Lautenbach, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966446
- Sponsor's protocol ID
- 809899
- Status last verified
- Jul 2019
- First submitted
- 25 Aug 2009
- Last updated
- 5 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28939607Cluzet 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.
PubMed 27465112
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology and Prevention of MRSA Transmission in the Community
- ClinicalTrials.gov ID
- NCT00966446
- Acronym / sponsor ID
- 809899
- Keywords
- MRSA; household; infection; colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health, Children's Hospital of Philadelphia, Milton S. Hershey Medical Center
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 27 Aug 2009 (estimated)
- Results
- Posted 29 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 identify host, microbiological and environmental risk factors for prolonged MRSA colonization, MRSA transmission and clinical MRSA infection among patients with MRSA skin and soft tissue infections (SSTIs) and their household contacts and to use stochastic agent-based modeling methods to quantify secondary spread of CO-MRSA in households.
- to evaluate the impact of a decolonization intervention on MRSA infections in the household.
- to identify immunological mechanisms underlying the ability of Streptococcus pneumoniae colonization to inhibit MRSA colonization, transmission and infection in order to identify potential future immunological targets for interventions.
- 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unsupervised Decolonization | Experimental | Drug: Unsupervised DecolonizationHouseholds 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 | Drug: Supervised DecolonizationHouseholds 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 |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All members of a household in which the index case is treated for a skin or soft tissue infection due to MRSA. All household members must agree to participate in order for the household to be enrolled
Key exclusion criteria (1 listed)
- Prior MRSA within past 6 months in the index case; age less than 6 months.
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 |
|---|---|---|
| Unsupervised DecolonizationAlso: Experimental: Unsupervised DecolonizationHouseholds 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. | Drug | Unsupervised Decolonization |
| Supervised DecolonizationAlso: Experimental: Supervised DecolonizationHouseholds 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. | Drug | Supervised Decolonization |
Primary outcome
Recurrent Infection
Time frame: Within 6 months
Confirmed new MRSA infections
First Two Consecutive Sampling Periods Completed
Time frame: Within 2 months
Subjects who returned samples for at least the first two consecutive sampling periods were included in analysis
1 secondary outcome
Time to Clearance of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Time frame: Within 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28939607Shahbazian 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.
- Derived from this study: PubMed 27465112Cluzet 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.
- Individual participant dataSharing planned: No
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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.
Ebbing Lautenbach, MD principal investigator
University of Pennsylvania
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unsupervised Decolonization and Supervised Decolonization in people with MRSA - Methicillin Resistant Staphylococcus Aureus Infection, run by University of Pennsylvania at 4 sites 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 1 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 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 29 Jun 2016). 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?
Recurrent Infection (time frame: Within 6 months). The study lists 2 primary outcomes in all. 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 NCT00966446, which also lists 2 linked publications.
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 5 Jul 2019.