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OpenTrials
Completed

NCT Number: NCT01438515

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint John Regional Hospital

Saint John, New Brunswick, E2L4L2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rifampin

Drug

600mg po once daily x 7 days

Doxycycline

Drug

100mg po twice daily x 7 days

2% mupirocin ointment

Other

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

4% chlorhexidine gluconate

Other

Daily full body wash (including hair) for 7 days

Primary outcomes

  1. Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months

    Time frame: 12 months

    To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.

Secondary outcomes

  1. Changes in susceptibility patterns of MRSA isolates.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Horizon Health Network

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2019
Study completion
2019
First posted
Sep 22, 2011
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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