Trials / Terminated
TerminatedNCT03219164
Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 149 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 3 Months – 18 Years
- Healthy volunteers
- Not accepted
Summary
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 pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZLI | Administered via the PARI Altera® Nebulizer System. Participants \< 2 years will receive via the SmartMask® Baby, 2 to \< 6 years via the SmartMask Kids® and \> 6 years via the nebulizer mouthpiece. |
| DRUG | Placebo | Administered via the PARI Altera® Nebulizer System. Participants \< 2 years will receive via the SmartMask® Baby, 2 to \< 6 years via the SmartMask Kids® and \> 6 years via the nebulizer mouthpiece. |
Timeline
- Start date
- 2017-11-28
- Primary completion
- 2020-05-27
- Completion
- 2021-09-23
- First posted
- 2017-07-17
- Last updated
- 2022-06-14
- Results posted
- 2022-05-16
Locations
53 sites across 12 countries: United States, Austria, Belgium, Denmark, France, Germany, Greece, Israel, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03219164. Inclusion in this directory is not an endorsement.