At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of cystic fibrosis by sweat chloride >60 mEq/L, two CF-consistent mutations, or abnormal nasal transepithelial potential difference with clinical features
- ✓Age ≥12 months
- ✓New-onset PA airway infection: first-ever documented PA culture OR PA recovered after ≥2 years of negative cultures (for age >15 months); or at least one positive PA culture for ages 12-15 months
- ✓Clinically stable without respiratory symptoms, abnormal chest X-ray findings, or need for IV anti-pseudomonal antibiotics, oxygen, or hospitalization
- ✕History of aminoglycoside hypersensitivity or adverse reaction to inhaled aminoglycoside
- ✕History of hypersensitivity or adverse reaction to ciprofloxacin or other fluoroquinolone medications
- ✕Persistent documented hearing loss on audiometry (≥2 occasions) not due to middle ear disease
- ✕Use of >1 course of IV anti-pseudomonal antibiotics (≥10 continuous days) or >1 course of inhaled anti-pseudomonal antibiotics (≥28 continuous days) within 2 years; any IV or inhaled anti-pseudomonal antibiotics must be stopped ≥30 days before study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis
In Brief
A Phase 2 clinical trial evaluating Tobramycin solution for inhalation (TOBI), Oral placebo, and 1 other intervention for Cystic Fibrosis and Pulmonary Disease, Chronic Obstructive. Completed, enrolled 304 participants across 54 sites.
Detailed 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.
Study Details
Timeline
Interventions
Tobramycin solution for inhalation, 300 mg, administered twice daily for 28 days administered only when quarterly respiratory cultures are found positive for Pa.
Oral placebo for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive placebo, twice daily.
Oral ciprofloxacin for six consecutive quarterly cycles. For the initial 14 days of the 28-day treatment period, the participants will receive oral ciprofloxacin, 15-20 mg/kg/dose, twice daily.