Comparison of Antibiotics for Pseudomonas in Early CF — CAPEC  

Cystic Fibrosis Clinical Trial

Official title: Comparison of Antibiotics for Pseudomonas in Early CF

Status Completed

Clinical Trial Summary

This is a prospective, randomized clinical trial comparing the effects of these 2 modes of antibiotic treatment on BALF inflammation in young, P. aeruginosa-positive CF patients.

Clinical Trial Description

Cystic fibrosis (CF) is a genetic disorder which is typically fatal during early adulthood, due to progressive bronchiectasis and respiratory failure. Chronic lung infection with Pseudomonas aeruginosa begins in early life and is clearly associated with decline (especially mucoid phenotypes), making this infection a major target of therapy. The inflammatory response to infection may also be dysregulated in CF, so that suppression of airway inflammation is a second major goal of therapy. However, "best practice" for treatment of Pseudomonas infection in early CF is not defined (several recently published commentaries available upon request) and is a critical issue currently in clinical management of CF. Inhaled tobramycin alone has been reported to be effective at short-term eradication of P. aeruginosa from bronchoalveolar lavage fluid (BALF) in children with cystic fibrosis (CF) age 3 mo-6 yr, but inflammation was unaffected by this treatment, and recurrence of infection occurred fairly quickly for mucoid strains. The ideal treatment would result in long-term reduction in both bacterial quantity and inflammation. Some bacteria in the CF airway may be both inaccessible to inhaled antibiotics, and "hidden" from BALF, by location in inspissated secretions, and P. aeruginosa may not be effectively eradicated in paranasal sinuses. Thus, it is reasonable to hypothesize that treatment with parenteral antibiotics provides better overall eradication of organisms and consequently reduced stimulus for ongoing or recurrent inflammation in the airways. We therefore propose a prospective, randomized clinical trial comparing the effects of these 2 modes of antibiotic treatment on BALF inflammation in young, P. aeruginosa-positive CF patients. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis

• NCT number: NCT00823238
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Status: Completed
• Phase: Phase 1
• Start date: July 2004
• Completion date: May 2008