Cystic Fibrosis Clinical Trial
Official title:
Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe)
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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