ALPINE 2: AZLI for children with CF and PA lung infection

Details

Therapeutic category
Anti-Infective
Trial status
Completed Participating Centres
Phase
Phase III

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

The 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
88959
Trial type
Medication
Length of participation
28 days
Intervention
Aztreonam antiobiotic
Recruitment target
140
Last edited date
15/12/2016
CF sponsor
Gilead Sciences
CF sponsor type
Commercial

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.

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