Aztreonam Lysine for Pseudomonas Infection Eradication Study
Status:
Completed
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
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 participants will be treated with a 28-day course of
Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug,
subjects will be followed up through Day 196 for safety and recurrence of PA.
The primary objective is to evaluate the proportion of participants with PA-negative cultures
at all time points during a 6-month monitoring period (through Day 196) after cessation of
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).