Stop Community MRSA Colonization Among Patients

NCT02029872 | Completed Phase 4 Results DMC

• 1 other identifier: NA_00079147
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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.

Conditions

MRSA

Keywords

MRSA; colonization; decolonization

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Study Arms (2)

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.

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.

Drug: Chlorhexidine gluconate soap; Drug: Chlorhexidine gluconate oral rinse; Drug: Mupirocin calcium 2 % ointment

Interventions

Chlorhexidine gluconate soap DRUG

4% chlorhexidine gluconate (soap)

Also known as: Hibiclens

Individual alone; Individual plus household

Chlorhexidine gluconate oral rinse DRUG

chlorhexidine gluconate oral rinse 0.12%

Also known as: Chlorhexidine

Individual alone; Individual plus household

Mupirocin calcium 2 % ointment DRUG

nasal mupirocin calcium 2% ointment

Also known as: Mupirocin

Individual alone; Individual plus household

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (23)

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MeSH Terms

Interventions

chlorhexidine gluconate; Chlorhexidine; Mupirocin; Ointments

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Epoxy Compounds; Ethers, Cyclic; Ethers; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fatty Acids; Lipids; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Jason Farley
• Organization: Johns Hopkins University School of Nursing

jfarley1@jhu.edu

4105027563

Study Officials

• Jason E Farley, PhD, MPH, NP

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2013
• First Posted: January 8, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 20, 2018
• Results First Posted: March 20, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)