ALPINE 2: AZLI for children with CF and PA lung infection
- Therapeutic category
- Trial status
- Completed Participating Centres
- Phase III
Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/ColonizationThe primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in participants with new onset Pseudomonas aeruginosa respiratory tract infection.
- Trial Reference Number
- Trial type
- Length of participation
- 28 days
- Aztreonam antiobiotic
- Recruitment target
- Last edited date
- CF sponsor
- Gilead Sciences
- CF sponsor type
Who can take part?
- Top inclusion criteria
- Age 3 months to less than 18 years old
- FEV1 ≥ 80% predicted (for subjects ≥ 6 years of age
- Documented new onset of positive respiratory tract culture for Pseudomonas Aeruginosa within 30 days of screening.
- Top exclusion criteria
- Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit).
- Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening visit.