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

This study is currently recruiting participants.
Verified September 2011 by Horizon Health Network, Saint John Zone
Sponsor:
Information provided by (Responsible Party):
Duncan Webster, Horizon Health Network, Saint John Zone
ClinicalTrials.gov Identifier:
NCT01438515
First received: September 21, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted

September 21, 2011
September 21, 2011
August 2008
Not Provided
Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months [ Designated as safety issue: No ]
To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.
Same as current
No Changes Posted
Changes in susceptibility patterns of MRSA isolates. [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Methicillin-resistant Staphylococcus Aureus
  • Drug: Rifampin
    600mg po once daily x 7 days
  • Drug: Doxycycline
    100mg po twice daily x 7 days
  • Other: 2% mupirocin ointment
    ~ 1cm applied to the anterior nares twice daily for 7 days
  • Other: 4% chlorhexidine gluconate
    Daily full body wash (including hair) for 7 days
  • Experimental: Systemic decolonization
    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)
    Interventions:
    • Drug: Rifampin
    • Drug: Doxycycline
    • Other: 2% mupirocin ointment
    • Other: 4% chlorhexidine gluconate
  • Active Comparator: Standard decolonization
    7-day course of 2% mupirocin ointment to the anterior nares twice daily and 4% chlorhexidine gluconate washes once per day.
    Interventions:
    • Other: 2% mupirocin ointment
    • Other: 4% chlorhexidine gluconate
Simor AE, Phillips E, McGeer A, Konvalinka A, Loeb M, Devlin HR, Kiss A. Randomized controlled trial of chlorhexidine gluconate for washing, intranasal mupirocin, and rifampin and doxycycline versus no treatment for the eradication of methicillin-resistant Staphylococcus aureus colonization. Clin Infect Dis. 2007 Jan 15;44(2):178-85. Epub 2006 Dec 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact: Paula Duffley, RN 5066487098 Paula.Duffley@HorizonNB.ca
Canada
 
NCT01438515
2008-1265
No
Duncan Webster, Horizon Health Network, Saint John Zone
Horizon Health Network, Saint John Zone
Not Provided
Principal Investigator: Duncan Webster, MA, MD Horizon Health Network, Saint John Zone
Horizon Health Network, Saint John Zone
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP