Clinical trial NCT01438515: Randomized Controlled Trial of Standard Versus Systemic Decolonization Therapy for the Eradication of Methicillin-resistant Staphylococcus Aureus (MRSA) Colonization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Methicillin-resistant Staphylococcus Aureus
Keywords: MRSA
doxycycline
rifampin
mupirocin
chlorhexidine gluconate
decolonization
methicillin-resistant staphylococcus aureus
Lead sponsor: Horizon Health Network
Sponsor class: OTHER
First posted: 2011-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rates of sustained decolonization at 1 month, 3 months, 6 months and 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Changes in susceptibility patterns of MRSA isolates.
timeFrame: 12 months
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
Study officials:
affiliation: Horizon Health Network
name: Duncan Webster, MA, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1086/510392. Epub 2006 Dec 14.