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

Methicillin-resistant Staphylococcus Aureus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438515
• Other study ID #: 2008-1265
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Horizon Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Methicillin-resistant Staphylococcus Aureus
• Staphylococcal Infections

Intervention

Drug:
• Rifampin
600mg po once daily x 7 days
• Doxycycline
100mg po twice daily x 7 days

Other:
• 2% mupirocin ointment
~ 1cm applied to the anterior nares twice daily for 7 days
• 4% chlorhexidine gluconate
Daily full body wash (including hair) for 7 days

Locations

Country	Name	City	State
Canada	Saint John Regional Hospital	Saint John	New Brunswick

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Health Network

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months	To compare standard versus systemic decolonization for their ability to sustain MRSA decolonization up to one year post-decolonization.	12 months
Secondary	Changes in susceptibility patterns of MRSA isolates.	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