Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
| Tracking Information | |||||
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| First Received Date ICMJE | September 21, 2011 | ||||
| Last Updated Date | September 21, 2011 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Methicillin-resistant Staphylococcus Aureus | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 200 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01438515 | ||||
| Other Study ID Numbers ICMJE | 2008-1265 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Duncan Webster, Horizon Health Network, Saint John Zone | ||||
| Study Sponsor ICMJE | Horizon Health Network, Saint John Zone | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Horizon Health Network, Saint John Zone | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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