NCT01375049

Aztreonam Lysine for Pseudomonas Infection Eradication Study

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 3 Months – 17 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Aztreonam for Inhalation Solution (AZLI)	AZLI 75 mg administered 3 times daily via the investigational eFlow® nebulizer

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2011-06-17
• Last updated: 2014-07-17
• Results posted: 2014-07-01

Locations

58 sites across 9 countries: United States, Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain