- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01438515
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Brunswick
-
Saint John, New Brunswick, Canada, E2L4L2
- Saint John Regional Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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)
|
600mg po once daily x 7 days
100mg po twice daily x 7 days
~ 1cm applied to the anterior nares twice daily for 7 days
Daily full body wash (including hair) for 7 days
|
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.
|
~ 1cm applied to the anterior nares twice daily for 7 days
Daily full body wash (including hair) for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Duncan Webster, MA, MD, Horizon Health Network
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Staphylococcal Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Dermatologic Agents
- Anti-Bacterial Agents
- Leprostatic Agents
- Protein Synthesis Inhibitors
- Cytochrome P-450 Enzyme Inducers
- Antiprotozoal Agents
- Antiparasitic Agents
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antimalarials
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Disinfectants
- Mupirocin
- Doxycycline
- Rifampin
- Chlorhexidine
- Chlorhexidine gluconate
Other Study ID Numbers
- 2008-1265
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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