ALPINE 2: AZLI for children with CF and PA lung infection
Details
- Therapeutic approach
- Anti-Infective
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001696
- Last updated
- 15/12/2016
Full title
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/Colonization
Study detailsThe 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.
- Phase
- Phase 3
- Length of participation
- 28 days
- Recruitment target
- 140
- CF sponsor
- Gilead Sciences
- CF sponsor type
- Commercial
Who can take part?
- Age range
- Between 3 months and 18 years
- Including people
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.
- Excluding people
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.