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

Randomized Controlled Trial of Chlorhexidine Gluconate, Intranasal Mupirocin, Rifampin and Doxycycline Versus Chlorhexidine Gluconate and Intranasal Mupirocin Alone for the Eradication of Methicillin-resistant Staphylococcus Aureus Among an Ambulatory Patient Population

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01438515

Enrollment

100

Registered

2011-09-22

Start date

2008-08-31

Completion date

2019-12-31

Last updated

2020-02-17

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

Conditions

Methicillin-resistant Staphylococcus Aureus

Keywords

MRSA, doxycycline, rifampin, mupirocin, chlorhexidine gluconate, decolonization, methicillin-resistant staphylococcus aureus

Brief summary

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.

Interventions

DRUGRifampin

600mg po once daily x 7 days

DRUGDoxycycline

100mg po twice daily x 7 days

OTHER2% mupirocin ointment

\ 1cm applied to the anterior nares twice daily for 7 days

OTHER4% chlorhexidine gluconate

Daily full body wash (including hair) for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months	12 months	To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.

Secondary

Measure	Time frame	Description
Changes in susceptibility patterns of MRSA isolates.	12 months	Study isolates will be evaluated with regards to mupirocin, rifampin and tetracycline resistance patterns, where individuals remain colonized, or re-colonize subsequent to implementation of the decolonization protocol.

Countries

Canada

Outcome results

None listed

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