MRSAPhase 4SUSTAINNCT02029872
Stop Community MRSA Colonization Among Patients
A Phase 4 study testing Chlorhexidine gluconate soap, Chlorhexidine gluconate oral rinse and Mupirocin calcium 2 % ointment in people with MRSA, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to learn more about an approach to remove Methicillin resistant Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient settings and among their household members and sexual partners. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- MRSA
- What is being tested?
- Chlorhexidine gluconate soap, Chlorhexidine gluconate oral rinse and Mupirocin calcium 2 % ointment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Mar 2017
- Phase
- Phase 4
- 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
- Individuals, 21 years of age and older, of all racial and ethnic groups, receiving care within the Johns Hopkins University AIDS Service who have a prior history of MRSA colonization are eligible to participate as the index HIV positive subject
- have at least two members in the household and/or a sexual partner
- subjects must be willing to be randomized to either arm of the study, including randomization to household and/or sexual partner evaluation that includes home visits
- Sexual partners and/or household members will also be required to provide informed consent
- Subjects and their contacts must have no documented or reported allergies to any agent used in the standardized decolonization regimen
- Parental assent will be required for household members less than 7 years of age
Who cannot join
- individuals who live alone and have no active sexual partners
- allergy to any component of decolonization protocol
- individuals who are unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stop Community MRSA Colonization Among Patients (SUSTAIN)
This research is being done to learn more about an approach to remove Methicillin resistant Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient settings and among their household members and sexual partners.
MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make people very sick. The bacteria have been seen in a high number of persons in the Baltimore area and in hospitals throughout the country. MRSA can be spread from person to person, particularly in homes and among family members and sexual partners.
Read more
There are three things the investigators hope to learn from this research study:
First, the investigators want to find a way to prevent MRSA infections in outpatient settings. By asking questions, the investigators want to look at the things that may increase the risk of having this type of bacteria in you and your family members.
Second, the investigators have soaps and oral rinses (Chlorhexidine) and medications (antibiotics; Mupirocin ointment) that have been shown to be effective at removing MRSA. The investigators want to determine if these antibiotics and soaps are best used for everyone in the household or only the individual with known MRSA.
Third, as the investigators, we want to learn more about the bacteria by looking at it on the inside. The investigators will do laboratory tests on samples we collect, to learn how MRSA bacteria grow, reproduce and how it develops to behave differently than other types of MRSA bacteria.
Read the detailed description
Methicillin resistant Staphylococcus aureus (MRSA) kills more patients in the United States (U.S.) than Acquired Immunodeficiency Syndrome (AIDS). Further, persons living with Human Immunodeficiency Virus (HIV) experience MRSA infection at significantly higher rates than the general population (12.3/ 1000 person years compared to 1 to 2/1000 person years) and MRSA remains a substantial reason for hospital admission among this patient population. Colonization with Staphylococcus aureus is a major risk factor for infection in persons living with HIV and AIDS (PLWHA) and eradication of MRSA colonization reduces the occurrence of subsequent infection in patients. Household contacts with MRSA colonization increase failure rates of decolonization. The clinical practice guidelines for MRSA management from the Infectious Diseases Society of America (IDSA) recommend providing decolonization to persons with repeated skin and soft tissue infections as well as their household contacts; however, the guidelines report that evidence is limited in support of this recommendation. Additionally, these recommendations do not include sexual partners outside the home and there is mounting evidence of MRSA transmission between sexual partners and sexual networks. Strategies that reduce the spread of MRSA among people living with HIV/AIDS (PLWHA) are vitally needed to reduce this disparity.
To assess colonization prevalence among PLWHA, investigators conducted an epidemiologic evaluation of MRSA among persons within the Johns Hopkins University AIDS Service (JHUAS). The study included 500 subjects (65.8 % male) along with the sexual partners of 35 subjects. The MRSA colonization prevalence was 16.8% among subjects and 37% (17/35) in their sexual partners (unpublished data). These findings demonstrate an exceptional difference in colonization prevalence in PLWHA compared to the US population and supports the need for further research to understand decolonization regimens that evaluate outcomes for individual decolonization only compared to the inclusion household and/or sexual partner interventions. We propose a randomized controlled trial (RCT) among 100 PLWHA (50 per arm) within the JHUAS to evaluate an individual versus household/sexual partner decolonization intervention.
The specific aims of the proposed RCT are:
- To compare a MRSA decolonization protocol for the colonized individual (index) versus the index plus their household member and/or routine sexual partner(s). H0: Index plus household/sexual partner(s) decolonization will be associated with a lower occurrence of MRSA colonization at 6 months after completion of decolonization protocol.
- To estimate the intervention effect size and develop an intervention fidelity assessment plan to scale the intervention into a larger multi-city R01 application.
- To determine the molecular characteristics and antimicrobial susceptibilities of both the clinical and colonizing isolates among index patient as well as household members.
- Conditions
- MRSA
- Being tested
- Chlorhexidine gluconate soap, Chlorhexidine gluconate oral rinse, Mupirocin calcium 2 % ointment
- Keywords
- MRSA, colonization, decolonization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconate soapDrug
Also called Hibiclens
4% chlorhexidine gluconate (soap)
Chlorhexidine gluconate oral rinseDrug
Also called Chlorhexidine
chlorhexidine gluconate oral rinse 0.12%
Mupirocin calcium 2 % ointmentDrug
Also called Mupirocin
nasal mupirocin calcium 2% ointment
| Study group | Role | What they receive |
|---|---|---|
| Individual plus household | Active comparator | Standard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days. Receives: Drug: Chlorhexidine gluconate soap; Drug: Chlorhexidine gluconate oral rinse; Drug: Mupirocin calcium 2 % ointment |
| Individual alone | Active comparator | Standard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days. Receives: Drug: Chlorhexidine gluconate soap; Drug: Chlorhexidine gluconate oral rinse; Drug: Mupirocin calcium 2 % ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Participants were decolonized with a standard Methicillin-resistant Staphylococcus aureus (MRSA) decolonization protocol and monitored for 6 months. This is the number of participants who screened positive for Methicillin-resistant Staphylococcus aureus (MRSA) 6 months after being decolonized (i.e., recurrent infection)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2017
- Study completionMar 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 (23)Papers the sponsor has linked to this study.
- Other trials for MRSAStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Jason E Farley, PhD, MPH, NP, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029872
- Sponsor's protocol ID
- NA_00079147
- Acronym
- SUSTAIN
- Status last verified
- Mar 2018
- First submitted
- 18 Dec 2013
- Last updated
- 20 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007 Oct 17;298(15):1763-71. doi: 10.1001/jama.298.15.1763.
PubMed 17940231Crum-Cianflone N, Weekes J, Bavaro M. Recurrent community-associated methicillin-resistant Staphylococcus aureus infections among HIV-infected persons: incidence and risk factors. AIDS Patient Care STDS. 2009 Jul;23(7):499-502. doi: 10.1089/apc.2008.0240.
PubMed 19530952Crum-Cianflone NF, Grandits G, Echols S, Ganesan A, Landrum M, Weintrob A, Barthel R, Agan B; Infectious Disease Clinical Research Program. Trends and causes of hospitalizations among HIV-infected persons during the late HAART era: what is the impact of CD4 counts and HAART use? J Acquir Immune Defic Syndr. 2010 Jul;54(3):248-57. doi: 10.1097/qai.0b013e3181c8ef22.
PubMed 20658748Shet A, Mathema B, Mediavilla JR, Kishii K, Mehandru S, Jeane-Pierre P, Laroche M, Willey BM, Kreiswirth N, Markowitz M, Kreiswirth BN. Colonization and subsequent skin and soft tissue infection due to methicillin-resistant Staphylococcus aureus in a cohort of otherwise healthy adults infected with HIV type 1. J Infect Dis. 2009 Jul 1;200(1):88-93. doi: 10.1086/599315.
PubMed 19463064Buehlmann M, Frei R, Fenner L, Dangel M, Fluckiger U, Widmer AF. Highly effective regimen for decolonization of methicillin-resistant Staphylococcus aureus carriers. Infect Control Hosp Epidemiol. 2008 Jun;29(6):510-6. doi: 10.1086/588201.
PubMed 18510460Ammerlaan HS, Kluytmans JA, Berkhout H, Buiting A, de Brauwer EI, van den Broek PJ, van Gelderen P, Leenders SA, Ott A, Richter C, Spanjaard L, Spijkerman IJ, van Tiel FH, Voorn GP, Wulf MW, van Zeijl J, Troelstra A, Bonten MJ; MRSA Eradication Study Group. Eradication of carriage with methicillin-resistant Staphylococcus aureus: determinants of treatment failure. J Antimicrob Chemother. 2011 Oct;66(10):2418-24. doi: 10.1093/jac/dkr250. Epub 2011 Jun 30.
PubMed 21719471Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4.
PubMed 21208910Crum-Cianflone NF, Shadyab AH, Weintrob A, Hospenthal DR, Lalani T, Collins G, Mask A, Mende K, Brodine SK, Agan BK; Infectious Disease Clinical Research Program HIV Working Group. Association of methicillin-resistant Staphylococcus aureus (MRSA) colonization with high-risk sexual behaviors in persons infected with human immunodeficiency virus (HIV). Medicine (Baltimore). 2011 Nov;90(6):379-389. doi: 10.1097/MD.0b013e318238dc2c.
PubMed 22033452Shadyab AH, Crum-Cianflone NF. Methicillin-resistant Staphylococcus aureus (MRSA) infections among HIV-infected persons in the era of highly active antiretroviral therapy: a review of the literature. HIV Med. 2012 Jul;13(6):319-32. doi: 10.1111/j.1468-1293.2011.00978.x. Epub 2012 Jan 25.
PubMed 22276696Graham PL 3rd, Lin SX, Larson EL. A U.S. population-based survey of Staphylococcus aureus colonization. Ann Intern Med. 2006 Mar 7;144(5):318-25. doi: 10.7326/0003-4819-144-5-200603070-00006.
PubMed 16520472Diep BA, Chambers HF, Graber CJ, Szumowski JD, Miller LG, Han LL, Chen JH, Lin F, Lin J, Phan TH, Carleton HA, McDougal LK, Tenover FC, Cohen DE, Mayer KH, Sensabaugh GF, Perdreau-Remington F. Emergence of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus clone USA300 in men who have sex with men. Ann Intern Med. 2008 Feb 19;148(4):249-57. doi: 10.7326/0003-4819-148-4-200802190-00204. Epub 2008 Jan 30.
PubMed 18283202Crum-Cianflone NF, Burgi AA, Hale BR. Increasing rates of community-acquired methicillin-resistant Staphylococcus aureus infections among HIV-infected persons. Int J STD AIDS. 2007 Aug;18(8):521-6. doi: 10.1258/095646207781439702.
PubMed 17686212Skiest DJ, Brown K, Cooper TW, Hoffman-Roberts H, Mussa HR, Elliott AC. Prospective comparison of methicillin-susceptible and methicillin-resistant community-associated Staphylococcus aureus infections in hospitalized patients. J Infect. 2007 May;54(5):427-34. doi: 10.1016/j.jinf.2006.09.012. Epub 2006 Oct 27.
PubMed 17070598Al-Rawahi GN, Schreader AG, Porter SD, Roscoe DL, Gustafson R, Bryce EA. Methicillin-resistant Staphylococcus aureus nasal carriage among injection drug users: six years later. J Clin Microbiol. 2008 Feb;46(2):477-9. doi: 10.1128/JCM.01596-07. Epub 2007 Nov 26.
PubMed 18039800Huang H, Cohen SH, King JH, Monchaud C, Nguyen H, Flynn NM. Injecting drug use and community-associated methicillin-resistant Staphylococcus aureus infection. Diagn Microbiol Infect Dis. 2008 Apr;60(4):347-50. doi: 10.1016/j.diagmicrobio.2007.11.001. Epub 2008 Feb 21.
PubMed 18178362
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Community MRSA Colonization Among Patients (SUSTAIN)
- ClinicalTrials.gov ID
- NCT02029872
- Acronym / sponsor ID
- SUSTAIN / NA_00079147
- Conditions
- MRSA
- Keywords
- MRSA, colonization, decolonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 20 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to learn more about an approach to remove Methicillin resistant Staphylococcus aureus (MRSA) in patients who are carriers of the bacteria in outpatient settings and among their household members and sexual partners.
MRSA is a type of bacteria or germ that can cause bad infections of the skin that can make people very sick. The bacteria have been seen in a high number of persons in the Baltimore area and in hospitals throughout the country. MRSA can be spread from person to person, particularly in homes and among family members and sexual partners.
There are three things the investigators hope to learn from this research study:
First, the investigators want to find a way to prevent MRSA infections in outpatient settings. By asking questions, the investigators want to look at the things that may increase the risk of having this type of bacteria in you and your family members.
Second, the investigators have soaps and oral rinses (Chlorhexidine) and medications (antibiotics; Mupirocin ointment) that have been shown to be effective at removing MRSA. The investigators want to determine if these antibiotics and soaps are best used for everyone in the household or only the individual with known MRSA.
Third, as the investigators, we want to learn more about the bacteria by looking at it on the inside. The investigators will do laboratory tests on samples we collect, to learn how MRSA bacteria grow, reproduce and how it develops to behave differently than other types of MRSA bacteria.
Detailed description
Methicillin resistant Staphylococcus aureus (MRSA) kills more patients in the United States (U.S.) than Acquired Immunodeficiency Syndrome (AIDS). Further, persons living with Human Immunodeficiency Virus (HIV) experience MRSA infection at significantly higher rates than the general population (12.3/ 1000 person years compared to 1 to 2/1000 person years) and MRSA remains a substantial reason for hospital admission among this patient population. Colonization with Staphylococcus aureus is a major risk factor for infection in persons living with HIV and AIDS (PLWHA) and eradication of MRSA colonization reduces the occurrence of subsequent infection in patients. Household contacts with MRSA colonization increase failure rates of decolonization. The clinical practice guidelines for MRSA management from the Infectious Diseases Society of America (IDSA) recommend providing decolonization to persons with repeated skin and soft tissue infections as well as their household contacts; however, the guidelines report that evidence is limited in support of this recommendation. Additionally, these recommendations do not include sexual partners outside the home and there is mounting evidence of MRSA transmission between sexual partners and sexual networks. Strategies that reduce the spread of MRSA among people living with HIV/AIDS (PLWHA) are vitally needed to reduce this disparity.
To assess colonization prevalence among PLWHA, investigators conducted an epidemiologic evaluation of MRSA among persons within the Johns Hopkins University AIDS Service (JHUAS). The study included 500 subjects (65.8 % male) along with the sexual partners of 35 subjects. The MRSA colonization prevalence was 16.8% among subjects and 37% (17/35) in their sexual partners (unpublished data). These findings demonstrate an exceptional difference in colonization prevalence in PLWHA compared to the US population and supports the need for further research to understand decolonization regimens that evaluate outcomes for individual decolonization only compared to the inclusion household and/or sexual partner interventions. We propose a randomized controlled trial (RCT) among 100 PLWHA (50 per arm) within the JHUAS to evaluate an individual versus household/sexual partner decolonization intervention.
The specific aims of the proposed RCT are:
- To compare a MRSA decolonization protocol for the colonized individual (index) versus the index plus their household member and/or routine sexual partner(s). H0: Index plus household/sexual partner(s) decolonization will be associated with a lower occurrence of MRSA colonization at 6 months after completion of decolonization protocol.
- To estimate the intervention effect size and develop an intervention fidelity assessment plan to scale the intervention into a larger multi-city R01 application.
- To determine the molecular characteristics and antimicrobial susceptibilities of both the clinical and colonizing isolates among index patient as well as household members.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual plus household | Active comparator | Drug: Chlorhexidine gluconate soap, Drug: Chlorhexidine gluconate oral rinse, Drug: Mupirocin calcium 2 % ointmentStandard decolonization regimen for individual plus household: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days. |
| Individual alone | Active comparator | Drug: Chlorhexidine gluconate soap, Drug: Chlorhexidine gluconate oral rinse, Drug: Mupirocin calcium 2 % ointmentStandard decolonization regimen for the individual alone: 7 day course of nasal mupirocin calcium 2% ointment applied inside the nose twice daily, plus a 4% chlorhexidine gluconate (soap) used in the shower/bath every day for 7 days. For individuals colonized within the throat we will add chlorhexidine gluconate oral rinse 0.12% used in a gargle and spit fashion twice daily for 7 days. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals, 21 years of age and older, of all racial and ethnic groups, receiving care within the Johns Hopkins University AIDS Service who have a prior history of MRSA colonization are eligible to participate as the index HIV positive subject
- have at least two members in the household and/or a sexual partner
- subjects must be willing to be randomized to either arm of the study, including randomization to household and/or sexual partner evaluation that includes home visits
- Sexual partners and/or household members will also be required to provide informed consent
- Subjects and their contacts must have no documented or reported allergies to any agent used in the standardized decolonization regimen
Key exclusion criteria (3 listed)
- individuals who live alone and have no active sexual partners
- allergy to any component of decolonization protocol
- individuals who are unable to provide written informed consent
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 |
|---|---|---|
| Chlorhexidine gluconate soapAlso: Hibiclens4% chlorhexidine gluconate (soap) | Drug | Individual alone, Individual plus household |
| Chlorhexidine gluconate oral rinseAlso: Chlorhexidinechlorhexidine gluconate oral rinse 0.12% | Drug | Individual alone, Individual plus household |
| Mupirocin calcium 2 % ointmentAlso: Mupirocinnasal mupirocin calcium 2% ointment | Drug | Individual alone, Individual plus household |
Primary outcome
Number of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
Time frame: 6 months
Participants were decolonized with a standard Methicillin-resistant Staphylococcus aureus (MRSA) decolonization protocol and monitored for 6 months. This is the number of participants who screened positive for Methicillin-resistant Staphylococcus aureus (MRSA) 6 months after being decolonized (i.e., recurrent infection)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17940231Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007 Oct 17;298(15):1763-71. doi: 10.1001/jama.298.15.1763.
- Background: PubMed 19530952Crum-Cianflone N, Weekes J, Bavaro M. Recurrent community-associated methicillin-resistant Staphylococcus aureus infections among HIV-infected persons: incidence and risk factors. AIDS Patient Care STDS. 2009 Jul;23(7):499-502. doi: 10.1089/apc.2008.0240.
- Background: PubMed 20658748Crum-Cianflone NF, Grandits G, Echols S, Ganesan A, Landrum M, Weintrob A, Barthel R, Agan B; Infectious Disease Clinical Research Program. Trends and causes of hospitalizations among HIV-infected persons during the late HAART era: what is the impact of CD4 counts and HAART use? J Acquir Immune Defic Syndr. 2010 Jul;54(3):248-57. doi: 10.1097/qai.0b013e3181c8ef22.
- Background: PubMed 19463064Shet A, Mathema B, Mediavilla JR, Kishii K, Mehandru S, Jeane-Pierre P, Laroche M, Willey BM, Kreiswirth N, Markowitz M, Kreiswirth BN. Colonization and subsequent skin and soft tissue infection due to methicillin-resistant Staphylococcus aureus in a cohort of otherwise healthy adults infected with HIV type 1. J Infect Dis. 2009 Jul 1;200(1):88-93. doi: 10.1086/599315.
- Background: PubMed 18510460Buehlmann M, Frei R, Fenner L, Dangel M, Fluckiger U, Widmer AF. Highly effective regimen for decolonization of methicillin-resistant Staphylococcus aureus carriers. Infect Control Hosp Epidemiol. 2008 Jun;29(6):510-6. doi: 10.1086/588201.
- Background: PubMed 21719471Ammerlaan HS, Kluytmans JA, Berkhout H, Buiting A, de Brauwer EI, van den Broek PJ, van Gelderen P, Leenders SA, Ott A, Richter C, Spanjaard L, Spijkerman IJ, van Tiel FH, Voorn GP, Wulf MW, van Zeijl J, Troelstra A, Bonten MJ; MRSA Eradication Study Group. Eradication of carriage with methicillin-resistant Staphylococcus aureus: determinants of treatment failure. J Antimicrob Chemother. 2011 Oct;66(10):2418-24. doi: 10.1093/jac/dkr250. Epub 2011 Jun 30.
- Background: PubMed 21208910Liu C, Bayer A, Cosgrove SE, Daum RS, Fridkin SK, Gorwitz RJ, Kaplan SL, Karchmer AW, Levine DP, Murray BE, J Rybak M, Talan DA, Chambers HF; Infectious Diseases Society of America. Clinical practice guidelines by the infectious diseases society of america for the treatment of methicillin-resistant Staphylococcus aureus infections in adults and children. Clin Infect Dis. 2011 Feb 1;52(3):e18-55. doi: 10.1093/cid/ciq146. Epub 2011 Jan 4.
- Background: PubMed 22033452Crum-Cianflone NF, Shadyab AH, Weintrob A, Hospenthal DR, Lalani T, Collins G, Mask A, Mende K, Brodine SK, Agan BK; Infectious Disease Clinical Research Program HIV Working Group. Association of methicillin-resistant Staphylococcus aureus (MRSA) colonization with high-risk sexual behaviors in persons infected with human immunodeficiency virus (HIV). Medicine (Baltimore). 2011 Nov;90(6):379-389. doi: 10.1097/MD.0b013e318238dc2c.
- Background: PubMed 22276696Shadyab AH, Crum-Cianflone NF. Methicillin-resistant Staphylococcus aureus (MRSA) infections among HIV-infected persons in the era of highly active antiretroviral therapy: a review of the literature. HIV Med. 2012 Jul;13(6):319-32. doi: 10.1111/j.1468-1293.2011.00978.x. Epub 2012 Jan 25.
- Background: PubMed 16520472Graham PL 3rd, Lin SX, Larson EL. A U.S. population-based survey of Staphylococcus aureus colonization. Ann Intern Med. 2006 Mar 7;144(5):318-25. doi: 10.7326/0003-4819-144-5-200603070-00006.
- Background: PubMed 18283202Diep BA, Chambers HF, Graber CJ, Szumowski JD, Miller LG, Han LL, Chen JH, Lin F, Lin J, Phan TH, Carleton HA, McDougal LK, Tenover FC, Cohen DE, Mayer KH, Sensabaugh GF, Perdreau-Remington F. Emergence of multidrug-resistant, community-associated, methicillin-resistant Staphylococcus aureus clone USA300 in men who have sex with men. Ann Intern Med. 2008 Feb 19;148(4):249-57. doi: 10.7326/0003-4819-148-4-200802190-00204. Epub 2008 Jan 30.
- Background: PubMed 17686212Crum-Cianflone NF, Burgi AA, Hale BR. Increasing rates of community-acquired methicillin-resistant Staphylococcus aureus infections among HIV-infected persons. Int J STD AIDS. 2007 Aug;18(8):521-6. doi: 10.1258/095646207781439702.
- 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.
Jason E Farley, PhD, MPH, NP principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chlorhexidine gluconate soap, Chlorhexidine gluconate oral rinse and Mupirocin calcium 2 % ointment in people with MRSA, run by Johns Hopkins University 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 6 inclusion and 3 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 20 Mar 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 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 Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization (time frame: 6 months). 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 NCT02029872, which also lists 23 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 20 Mar 2018.