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Stop Community MRSA Colonization Among Patients

Stop Community MRSA Colonization Among Patients (SUSTAIN)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02029872
Acronym
SUSTAIN
Enrollment
77
Registered
2014-01-08
Start date
2014-01-31
Completion date
2017-03-31
Last updated
2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRSA

Keywords

MRSA, colonization, decolonization

Brief 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. 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: 1. 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. 2. To estimate the intervention effect size and develop an intervention fidelity assessment plan to scale the intervention into a larger multi-city R01 application. 3. To determine the molecular characteristics and antimicrobial susceptibilities of both the clinical and colonizing isolates among index patient as well as household members.

Interventions

DRUGChlorhexidine gluconate soap

4% chlorhexidine gluconate (soap)

chlorhexidine gluconate oral rinse 0.12%

DRUGMupirocin calcium 2 % ointment

nasal mupirocin calcium 2% ointment

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization6 monthsParticipants 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)

Countries

United States

Participant flow

Recruitment details

Recruitment took place from January 2014-March 2015 in an outpatient HIV clinic in Baltimore, Maryland

Pre-assignment details

Enrolled participants were screened for Methicillin-resistant Staphylococcus aureus (MRSA). Only those with a positive MRSA swab in any body site (nares, throat, perineum, rectum, vagina) were randomized to an arm of the study to receive the decolonization protocol.

Participants by arm

ArmCount
Individual Alone
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. Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap) Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12% Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
9
Individual Plus Household
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. Chlorhexidine gluconate soap: 4% chlorhexidine gluconate (soap) Chlorhexidine gluconate oral rinse: chlorhexidine gluconate oral rinse 0.12% Mupirocin calcium 2 % ointment: nasal mupirocin calcium 2% ointment
9
Total18

Baseline characteristics

CharacteristicIndividual Plus HouseholdIndividual AloneTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants0 Participants2 Participants
Age, Categorical
Between 18 and 65 years
7 Participants9 Participants16 Participants
Age, Continuous51.4 years
STANDARD_DEVIATION 12.2
50.6 years
STANDARD_DEVIATION 4.2
50.7 years
STANDARD_DEVIATION 10
Cluster of Differentiation 4 (CD4) T-cell count687 cells/mm^3
STANDARD_DEVIATION 223
676 cells/mm^3
STANDARD_DEVIATION 451
682 cells/mm^3
STANDARD_DEVIATION 345
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants9 Participants18 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
HIV Viral Load of <20 detectable copies of HIV viral load8 Participants6 Participants14 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
7 Participants6 Participants13 Participants
Race (NIH/OMB)
More than one race
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
1 Participants2 Participants3 Participants
Region of Enrollment
United States
9 Participants9 Participants18 Participants
Sex: Female, Male
Female
5 Participants7 Participants12 Participants
Sex: Female, Male
Male
4 Participants2 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 9
other
Total, other adverse events
1 / 90 / 9
serious
Total, serious adverse events
0 / 90 / 9

Outcome results

Primary

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)

Time frame: 6 months

Population: Only participants who received the decolonization protocol and completed the 6 month follow-up visit (7 for individual alone' and 6 for 'Individual plus household') were included in the analysis. The rest were lost to follow up

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Individual AloneNumber of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization2 Participants
Individual Plus HouseholdNumber of Participants With Recurrent Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization3 Participants
Comparison: Due to low enrollment in the intervention, statistical analysis was not possible.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026