drugset / Trial / NCT01349192

Summary

Purpose: There has been a recent, rapid increase in prevalence of Methicillin-resistant Staphylococcus aureus (MRSA) among patients with Cystic Fibrosis (22% across US CF centers in 2009). Some epidemiologic studies suggest possible worse outcomes, a recent analyses showing this with chronic but not intermittent MRSA. Given the chronic difficult to treat lung infections in CF it is unclear how the onset of MRSA should be approached. This randomized, controlled, interventional study seeks to determine if an early eradication protocol is effective for eradication of MRSA and will provide an opportunity to obtain data regarding early clinical impact of new isolation of MRSA. Participants: Cystic fibrosis patients with new isolation of MRSA from their respiratory culture on a routine clinic visit. Procedures (methods): Randomized, open-label, multi-center study comparing use of an eradication protocol to an observational group who receives the current standard of care i.e. treatment for MRSA only with pulmonary exacerbations.

Timeline

Start
2011-04
Primary completion
2015-01
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Chlorhexidine gluconate Other / unclassified 0.12 % Oral
Subject Chlorhexidine gluconate Other / unclassified 2 % Oral
Subject Minocycline Small molecule 2 mg/kg Oral
Subject Minocycline Small molecule 100 mg Oral
Subject Mupirocin Small molecule 2 % Intranasal
Subject Mupirocin Small molecule 1 g Intranasal
Subject Rifampin Small molecule 15 mg/kg
Subject Rifampin Small molecule 300 mg
Subject Sulfamethoxazole Small molecule 40 mg/kg
Subject Sulfamethoxazole Small molecule 1600 mg
Subject Trimethoprim Small molecule 8 mg/kg
Subject Trimethoprim Small molecule 320 mg