ClinicalTrials.gov record
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
ClinicalTrials.gov ID: NCT01641822
Public ClinicalTrials.gov record NCT01641822. 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
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis
Study identification
- NCT ID
- NCT01641822
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Gilead Sciences
- Industry
- Enrollment
- 107 participants
Conditions and interventions
Conditions
Interventions
- AZLI Drug
- Placebo to match AZLI Drug
- Tobramycin inhalation solution Drug
Drug
Eligibility (public fields only)
- Age range
- 6 Years and older
- 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 30, 2012
- Primary completion
- Dec 31, 2014
- Completion
- Dec 31, 2014
- Last update posted
- May 8, 2016
2012 – 2015
United States locations
- U.S. sites
- 71
- U.S. states
- 35
- U.S. cities
- 65
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| University of California - San Diego | La Jolla | California | 92093 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Kaiser Permanente Medical Center | Oakland | California | 94611 | — |
| National Jewish Health | Denver | Colorado | 80206 | — |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Central Florida Pulmonary Group | Altamonte Springs | Florida | 32701 | — |
| University of Florida | Gainesville | Florida | 32610 | — |
| South Broward Hospital dba Memorial Healthcare System | Hollywood | Florida | 33021 | — |
| Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | 32207 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32801 | — |
| Arnold Palmer Hospital for Children | Orlando | Florida | 32806 | — |
| Nemour's Children's Clinic | Pensacola | Florida | 32504 | — |
| All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Emory Cystic Fibrosis Center | Atlanta | Georgia | 30084 | — |
| Georgia Health | Augusta | Georgia | 30912 | — |
| St. Lukes Medical Center | Boise | Idaho | 37012 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Chicago CF Care Specialists NFP dba Cystic Fibrosis Institure | Glenview | Illinois | 60025 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Maine Medical Center | Portland | Maine | 38103 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Harper University Hospital | Detroit | Michigan | 48201 | — |
| Spectrum Health - Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| St. Louis University - Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Children's Lung Specialists | Las Vegas | Nevada | 89107 | — |
| Dartmouth Hitchcock Specialty Care Clinic | Bedford | New Hampshire | 03110 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Morristown Medical Center | Morristown | New Jersey | 07962 | — |
| UNM Clinical and Translational Center | Albuquerque | New Mexico | 87131 | — |
| Albany Medical College | Albany | New York | 12208 | — |
| Long Island Jewish Medical Center - Adult CF & Bronchiectasis Center | New Hyde Park | New York | 11042 | — |
| Gunnar Esiason Adult CF and Lung Program | New York | New York | 10032 | — |
| SUNY Upstate University | Syracuse | New York | 13210 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| UC Health - University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| The Toledo Hospital/Toledo Children's Hospital CF Center | Toledo | Ohio | 43606 | — |
| OU Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Santiago Reyes, MD | Oklahoma City | Oklahoma | 73112 | — |
| Geisinger Clinic | Danville | Pennsylvania | 17822 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Drexel University College of Medicine | Philadelphia | Pennsylvania | 19107 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| East Tennessee Children's Hospital | Knoxville | Tennessee | 37916 | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | 37920 | — |
| Children's Foundation Research Institute/UTHSC | Memphis | Tennessee | 28103 | — |
| Vanderbilt Children's Hospital | Nashville | Tennessee | 37232 | — |
| Austin Children's Chest Associates | Austin | Texas | 78723 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Alamo Clinical Research Associates | San Antonio | Texas | 78212 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Vermont Lung Center at the University of Vermont | Colchester | Vermont | 05446 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23510 | — |
| VCU Children's Hospital | Richmond | Virginia | 23298 | — |
| West Virginia University | Morgantown | West Virginia | 26506 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01641822, 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 May 8, 2016 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01641822 live on ClinicalTrials.gov.