Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization

Horizon Health Network

Status: Completed

Conditions: Methicillin-resistant Staphylococcus Aureus

Treatments: Other: 2% mupirocin ointment; Drug: Rifampin; Drug: Doxycycline; Other: 4% chlorhexidine gluconate

Study type: Interventional

Funder types: Other

Identifiers

NCT01438515

2008-1265

Details and patient eligibility

About

MRSA decolonization may reduce the risk of subsequent MRSA infection and further transmission. A recent randomized controlled trial demonstrated that systemic decolonization may be safe and effective among hospitalized patients when compared to no treatment. As a large number of the investigators patients require re-admission and further transmission may take place in the community, the investigators are comparing the standard decolonization protocol for MRSA eradication to the systemic decolonization protocol among an ambulatory population.

Standard decolonization protocols, which use only topical agents, are limited in efficacy. The method of systemic decolonization to be studied here appears to have greater efficacy than the standard approach using only topical agents. However, concerns have been raised that the increased use of systemic antibiotics may lead to increased levels of drug resistance adverse effects, without sustained decolonization. This study seeks to provide further data to help answer these questions and provide guidance for further policy development and implementation.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any patient colonized with MRSA

Exclusion criteria

• Currently on treatment with antibiotics
• Pregnant or breastfeeding women
• Active infection
• Hepatic cirrhosis or abnormal INR due to liver disease
• Decolonization in the previous two (2) months
• MRSA bacteria resistant to one or more of the study medications
• AST and ALT levels more than five times the upper limit of normal.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Systemic decolonization

Experimental group

Description:

7-day course of 4% chlorhexidine gluconate daily washes and 2% mupirocin ointment to the anterior nares twice daily in addition to oral rifampin (600mg daily), and doxycycline (100mg twice daily)

Treatment:

Drug: Rifampin

Other: 4% chlorhexidine gluconate

Drug: Doxycycline

Other: 2% mupirocin ointment

Standard decolonization

Active Comparator group

Description:

7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.

Treatment:

Other: 4% chlorhexidine gluconate

Other: 2% mupirocin ointment