Bacterial Infection, Cystic Fibrosis
Conditions
Keywords
bacterial infection, cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, immunologic disorders and infectious disorders, rare disease
Brief summary
OBJECTIVES: I. Determine the safety and efficacy of tobramycin in patients with cystic fibrosis who are chronically colonized with Pseudomonas aeruginosa. II. Determine whether this treatment produces tobramycin-resistant bacteria at a frequency different from the placebo group and whether the emergence of resistance is associated with a lack of clinical response.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients receive tobramycin or placebo by inhalation twice daily for 28 days followed by 28 days of rest. This treatment is repeated twice, for a total of 3 courses of therapy. Patients are followed every 2 weeks for the first 8 weeks, then every 4 weeks, and then at 4 weeks after the last treatment.
Interventions
DRUGtobramycin
Sponsors
FDA Office of Orphan Products Development
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Documented cystic fibrosis with Pseudomonas aeruginosa present in a sputum or throat culture within 6 months prior to screening Sweat chloride at least 60 mEq/L --Prior/Concurrent Therapy-- At least 14 days since prior intravenous or aerosolized tobramycin or other antipseudomonal antibiotic At least 4 weeks since prior administration of any investigational drug No concurrent antibiotics by aerosol --Patient Characteristics-- Renal: * Creatinine less than 2 mg/dL * BUN less than 40 mg/dL * No proteinuria of 2+ or greater Pulmonary: * FEV1 at least 75% and at least 25% of predicted * Room air oximetry at least 88% saturation * Able to perform pulmonary function tests * No hemoptysis of 60 mL or greater within 30 days prior to study * No abnormal chest X-ray Other: * Not pregnant * Fertile females must use effective contraception * No history of positive culture with Burkholderia cepacia * No history of glucose-6-phosphate dehydrogenase deficiency * No known local or systemic hypersensitivity to aminoglycosides, albuterol, or other beta-2 agonists
Outcome results
None listed