Stop Community MRSA Colonization Among Patients

NCT ID: NCT02029872

Last Updated: 2018-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2017-03-31

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.

Conditions

MRSA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine gluconate soap

Intervention Type: DRUG

4% chlorhexidine gluconate (soap)

Chlorhexidine gluconate oral rinse

Intervention Type: DRUG

chlorhexidine gluconate oral rinse 0.12%

Mupirocin calcium 2 % ointment

Intervention Type: DRUG

nasal mupirocin calcium 2% ointment

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.

Group Type: ACTIVE_COMPARATOR

Chlorhexidine gluconate soap

Intervention Type: DRUG

4% chlorhexidine gluconate (soap)

Chlorhexidine gluconate oral rinse

Intervention Type: DRUG

chlorhexidine gluconate oral rinse 0.12%

Mupirocin calcium 2 % ointment

Intervention Type: DRUG

nasal mupirocin calcium 2% ointment

Interventions

Chlorhexidine gluconate soap

4% chlorhexidine gluconate (soap)

Intervention Type: DRUG

Chlorhexidine gluconate oral rinse

chlorhexidine gluconate oral rinse 0.12%

Intervention Type: DRUG

Mupirocin calcium 2 % ointment

nasal mupirocin calcium 2% ointment

Intervention Type: DRUG

Other Intervention Names

Hibiclens; Chlorhexidine; Mupirocin

Eligibility Criteria

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

• Minimum Eligible Age: 6 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jason E Farley, PhD, MPH, NP

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

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Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NA_00079147

Identifier Type: -

Identifier Source: org_study_id