Overview

Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis

Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
0
Participant gender:
All
Summary
Cystic fibrosis (CF) is a chronic disease that significantly affects an individual's lung function. Antibiotic medications have been proven effective at reducing Pseudomonas aeruginosa (PA) infection, which is one of the main causes of death in individuals with CF. The purpose of this study is to compare the effectiveness of treatment based on quarterly culture results versus consistent quarterly antibiotic treatment at reducing PA infection in children with CF.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seattle Children's Hospital
Collaborators:
CF Therapeutics Development Network Coordinating Center
Cystic Fibrosis Foundation
Cystic Fibrosis Foundation Therapeutics
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Ciprofloxacin
Pharmaceutical Solutions
Tobramycin
Criteria
Inclusion Criteria:

- Diagnosis of CF, as determined by the 1997 CF Consensus Conference criteria: sweat
chloride level greater than 60 milliequivalent/liter (mEq/L) by quantitative
pilocarpine iontophoresis; or a genotype with two identifiable mutations consistent
with CF; or an abnormal nasal transepithelial potential difference and one or more
clinical features consistent with CF

- For participants greater than 15 months of age: documented new onset of positive
oropharyngeal, sputum, or lower respiratory tract culture for PA within 6 months of
study entry, defined as either: 1) first lifetime documented PA positive culture; or
2) PA recovered after at least a 2-year history of PA negative respiratory cultures
(at least one culture per year)

- For participants 12-15 months of age: at least one documented positive oropharyngeal,
sputum, or lower respiratory tract culture for PA since birth or CF diagnosis

- Clinically stable with no evidence of any significant respiratory symptoms or chest
radiograph findings at screening that would require administration of intravenous
anti-pseudomonal antibiotics, oxygen supplementation, or hospitalization

Exclusion Criteria:

- History of aminoglycoside hypersensitivity or adverse reaction to inhaled
aminoglycoside

- History of hypersensitivity or adverse reaction to ciprofloxacin or other
fluoroquinolone medications

- History of persistent, unresolved hearing loss documented by audiometric testing on at
least two occasions and not associated with middle ear disease or an abnormal
tympanogram

- Abnormal kidney function at study entry (defined as a serum creatinine level greater
than 1.5 times the upper limit of normal for participant's age)

- Abnormal liver function test results at study entry (defined as alanine
aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels greater than two
times the upper limit of normal range)

- Use of any investigational drug within 30 days of study entry

- Use of loop diuretics, phenytoin, warfarin, theophylline, or other methylxanthines
within 30 days of study entry

- Use of more than one course of intravenous anti-pseudomonal antibiotics (at least 10
continuous days of medication use) or more than one course of inhaled anti-pseudomonal
antibiotics (at least 28 continuous days of medication use) within 2 years of study
entry; intravenous or inhaled anti-pseudomonal antibiotics must be stopped at least 30
days prior to study entry

- Chronic macrolide use (more than 90 day duration) in the 3 months prior to study entry

- Presence of a condition or abnormality that would compromise the participant's safety
or the quality of the study data, in the opinion of the investigator