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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cystic Fibrosis, Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT00097773

Run by

Seattle Children's Hospital

People needed

304

Starts

2004-09-01

Expected to finish

2009-08-01

Last updated by the study team

2014-02-28

Who can join

Age: 1 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital of Los Angeles — Los Angeles, California, United States
• Northern California Kaiser Cystic Fibrosis Center — Oakland, California, United States
• Stanford University — Palo Alto, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's Hospital Denver — Aurora, Colorado, United States
• duPont Hospital for Children — Wilmington, Delaware, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• All Children's Hospital Cystic Fibrosis Center — St. Petersburg, Florida, United States
• Emory University Cystic Fibrosis Center — Atlanta, Georgia, United States
• Medical College of Georgia — Augusta, Georgia, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• Riley Hospital/Indiana University — Indianapolis, Indiana, United States
• University of Iowa — Iowa City, Iowa, United States
• University of Kentucky — Lexington, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Children's Hospital, Boston — Boston, Massachusetts, United States
• University of Massachusetts Memorial Health Care — Worcester, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Spectrum Health Hospitals - DeVos Children's — Grand Rapids, Michigan, United States
• Children's Hospitals & Clinics — Minneapolis, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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