Aztreonam Lysine for Pseudomonas Infection Eradication Study (ALPINE)
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with Cystic Fibrosis (CF) and newly detected Pseudomonas Aeruginosa (PA) pulmonary colonization/infection. All eligible subjects will begin a 28-day course of AZLI 75 mg 3 times daily (TID). After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA)|
- Proportion of patients with PA-negative cultures [ Time Frame: Through 6 month follow-up ] [ Designated as safety issue: No ]To evaluate the proportion of patients with PA-negative microbiological cultures at all time points during a 6 month monitoring period (through Day 196) after cessation of 28 day course of AZLI.
|Study Start Date:||August 2011|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Aztreonam Lysine for Inhalation (AZLI)
Aztreonam Lysine for inhalation dosing TID using the investigational eFlow nebulizer (AZLI 75 mg TID)
Drug: Aztreonam Lysine for Inhalation (AZLI)
75 mg three times a day (TID)
Other Name: Cayston
This is an open-label, multicenter study in pediatric patients age 3 months to less than 18 years with CF and newly detected PA pulmonary colonization/infection. The primary objective of this study is to evaluate the proportion of patients with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of Aztreonam for Inhalation Solution (AZLI) treatment; microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).
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|Study Director:||Mark Bresnik, MD||Gilead Sciences|