Article

Early anti-pseudomonal acquisition in young patients with cystic fibrosis: rationale and design of the EPIC clinical trial and observational study'.

Department of Anesthesiology and Pain Medicine, University of Washington School of Medicine, Seattle, WA 98104, USA.
Contemporary clinical trials (impact factor: 1.51). 02/2009; 30(3):256-68. DOI:10.1016/j.cct.2009.01.003 pp.256-68
Source: PubMed

ABSTRACT The primary cause of morbidity and mortality in patients with cystic fibrosis (CF) is progressive obstructive pulmonary disease due to chronic endobronchial infection, particularly with Pseudomonas aeruginosa (Pa). Risk factors for and clinical impact of early Pa infection in young CF patients are less well understood.
The present studies are designed to evaluate risk factors and outcomes associated with early Pa acquisition, and the benefits and harms of four anti-pseudomonal treatment regimens in young CF patients initiated after the first Pa positive respiratory culture.
The Early Pseudomonas Infection Control (EPIC) program consists of two studies, a randomized multicenter trial in CF patients ages 1-12 years at first isolation of Pa from a respiratory culture, and a longitudinal cohort study enrolling Pa-negative patients. Using a factorial design, trial participants are assigned for 18 months to either anti-pseudomonal treatment on a scheduled quarterly basis (cycled therapy) or based on recovery of Pa from quarterly respiratory cultures (culture-based therapy). The study drugs include inhaled tobramycin (300 mg BID) for 28 days, combined with either oral ciprofloxacin (15-20 mg/kg BID) or oral placebo for 14 days. The primary endpoints of the trial are the time to pulmonary exacerbation requiring IV antibiotics or hospitalization for respiratory symptoms, and the proportion of patients with new Pa-positive respiratory cultures during the study. The broad goals of the observational study are to describe the risk factors and outcomes associated with early acquisition of Pa. 306 patients were randomized in the clinical trial and 1787 were enrolled in the cohort study.
These companion studies will provide valuable epidemiological and microbiological information on early CF lung disease and Pa acquisition, and safety and clinical efficacy data on anti-pseudomonal treatment strategies for early Pa infections in the airways of young children with CF.

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    Journal of Pediatric Psychology 01/2004; 28(8):535-45. · 2.91 Impact Factor
Data provided are for informational purposes only. Although carefully collected, accuracy cannot be guaranteed. The impact factor represents a rough estimation of the journal's impact factor and does not reflect the actual current impact factor. Publisher conditions are provided by RoMEO. Differing provisions from the publisher's actual policy or licence agreement may be applicable.

Keywords

anti-pseudomonal treatment regimens
 
anti-pseudomonal treatment strategies
 
broad goals
 
CF lung disease
 
CF patients ages 1-12 years
 
chronic endobronchial infection
 
clinical efficacy data
 
clinical trial
 
first Pa positive respiratory culture
 
IV antibiotics
 
new Pa-positive respiratory cultures
 
Pseudomonas Infection Control
 
randomized multicenter trial
 
respiratory symptoms
 
risk factors
 
scheduled quarterly basis
 
study drugs
 
valuable epidemiological
 
young CF patients
 
young children