Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization, Cystic Fibrosis
In brief
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.
Key facts
- Study ID
- NCT03219164
- Run by
- Gilead Sciences
- People needed
- 149
- Starts
- 2017-11-28
- Expected to finish
- 2021-09-23
- Last updated by the study team
- 2022-06-14
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's National Health System — Washington D.C., District of Columbia, United States
- Johns Hopkins All Children's Hospital Outpatient Care Center — St. Petersburg, Florida, United States
- Ann & Robert H Lurie Childrens Hospital of Chicago — Chicago, Illinois, United States
- Corner Children's Hospital — Chicago, Illinois, United States
- University of Mississippi Medical center — Jackson, Mississippi, United States
- Clinical Research of Charlotte — Charlotte, North Carolina, United States
- Cleveland Clinic — Cleveland, Ohio, United States
- USC Department of Pediatrics/Division of Pediatric Pulmonology — Columbia, South Carolina, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- The University of Texas Health Science Center at Tyler — Tyler, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
- Medizinische Universitat Graz — Graz, Austria
- Medizinische Universitat Innsbruck — Innsbruck, Austria
- Hopital Universitaire des Enfants Reine Fabiola — Brussels, Belgium
- UZ Antwerpen — Edegem, Belgium
- Aarhus University Hospital — Aarhus N, Denmark
- Rigshospitalet — Copenhagen, Denmark
- Hopital des enfants - GH Pellegrin — Bordeaux, France
- CHU Grenoble Alpes — Grenoble, France
- Hopital Robert Debre APHP — Paris, France
- Universitatsklinikum Essen — Essen, Germany
- Stadtisches Krankenhaus Kiel — Kiel, Germany
- General Hospital of Thessaloniki,3rd Dept of Pediatrics — Thessaloniki, Greece
- Rambam Health Corporation — Haifa, Israel
- University of California San Francisco (UCSF) - Benioff Children's Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
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