Phase 2
N=304
Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis
Cystic Fibrosis · Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT00097773 ↗Enrolled (actual)
304
Serious AEs
27.3%
Results posted
Nov 2013
Primary outcome: Primary: Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization — 24; 26; 29; 21 number of participants — p=0.86
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Tobramycin solution for inhalation (TOBI) (Drug); Oral placebo (Drug); Oral ciprofloxacin (Drug)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- Seattle Children's Hospital
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Pulmonary Exacerbation Requiring IV Antibiotics or Hospitalization |
24; 26; 29; 21 | 0.86 |
| SECONDARY Proportion of Participants With a Pa Positive Culture |
109; 85; 97; 97; 17; 38 | 0.28 |
| SECONDARY Number of Participants With a Pulmonary Exacerbation Requiring Oral, Inhaled, or Oral Antibiotics |
70; 81; 83; 68 | 0.18 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00097773). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.