Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
Public ClinicalTrials.gov record NCT03219164. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT03219164
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Gilead Sciences
- Industry
- Enrollment
- 149 participants
Conditions and interventions
Interventions
- AZLI Drug
- Placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 3 Months to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 27, 2017
- Primary completion
- May 26, 2020
- Completion
- Sep 22, 2021
- Last update posted
- Jun 13, 2022
2017 – 2021
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Francisco (UCSF) - Benioff Children's Hospital | San Francisco | California | 94158 | — |
| Children's National Health System | Washington D.C. | District of Columbia | 20010 | — |
| Johns Hopkins All Children's Hospital Outpatient Care Center | St. Petersburg | Florida | 33701 | — |
| Ann & Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Corner Children's Hospital | Chicago | Illinois | 60637 | — |
| University of Mississippi Medical center | Jackson | Mississippi | 39216 | — |
| Clinical Research of Charlotte | Charlotte | North Carolina | 28277 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| USC Department of Pediatrics/Division of Pediatric Pulmonology | Columbia | South Carolina | 29203 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| The University of Texas Health Science Center at Tyler | Tyler | Texas | 75708 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03219164, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 13, 2022 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03219164 live on ClinicalTrials.gov.