OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
Public ClinicalTrials.gov record NCT02054156. 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
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this trial is to compare the effects of treatment with tobramycin solution for inhalation (TIS) with and without azithromycin in people with cystic fibrosis (CF) age 6 months to 18 years who have early isolation of Pseudomonas aeruginosa (Pa) from a respiratory culture. Specimens of blood and sputum or throat swabs will be taken during the study along with pulmonary function testing. Participants will receive initial treatment with TIS followed additional treatment with TIS if quarterly respiratory cultures are positive for Pa in addition to either azithromycin or placebo for 18 months.
Study identification
- NCT ID
- NCT02054156
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 221 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 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
- Jun 2014 (Type not available)
- Primary completion
- Aug 23, 2018 (Actual)
- Completion
- Aug 23, 2018 (Actual)
- Last update posted
- Oct 1, 2019
2014 – 2018
United States locations
- U.S. sites
- 45
- U.S. states
- 30
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CFF Affiliate Program Providence Medical Center | Anchorage | Alaska | 99519-6604 | — |
| CFF Care Center Arizona Health Science Center | Tucson | Arizona | 85724 | — |
| CFF Care Center & Pediatric Program Arkansas Children's Hospital | Little Rock | Arkansas | 72202 | — |
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | — |
| CFF Care Center & Pediatric Program Stanford University | Palo Alto | California | 94304 | — |
| CFF Care Center & Pediatric Program Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| CFF Care Center & Pediatric Program Yale University | New Haven | Connecticut | 06520 | — |
| CFF Care Center & Pediatric Program Nemours Children's Clinic - Jacksonville | Jacksonville | Florida | 32207 | — |
| CFF Care Center & Pediatric Program All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| CFF Care Center & Pediatric Program Emory University | Atlanta | Georgia | 30324 | — |
| CFF Affiliate Program Children's Healthcare of Atlanta | Atlanta | Georgia | 30342 | — |
| CFF Care Center St. Luke's CF Clinic | Boise | Idaho | 83712 | — |
| CFF Care Center & Pediatric Program Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611-2605 | — |
| CFF Care Center & Pediatric Program Riley Hospital for Children | Indianapolis | Indiana | 46202-5271 | — |
| CFF Care Center & Pediatric Program University of Iowa | Iowa City | Iowa | 52242 | — |
| CFF Care Center & Pediatric Program Maine Medical Center | Portland | Maine | 04102 | — |
| CFF Care Center & Pediatric Program Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| CFF Care Center & Pediatric Program University of Michigan | Ann Arbor | Michigan | 48109-5212 | — |
| CFF Care Center & Pediatric Program Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| CFF Care Center The Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| CFF Care Center & Pediatric Program Cardinal Glennon Children's Hospital/Saint Louis University | St Louis | Missouri | 63104 | — |
| CFF Care Center & Pediatric Program St. Louis Children's Hospital | St Louis | Missouri | 63110 | — |
| CFF Care Center & Pediatric Program University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| CFF Care Center & Pediatric Program Monmouth Medical Center | Long Branch | New Jersey | 07740 | — |
| CFF Care Center & Pediatric Program Columbia University | New York | New York | 10032 | — |
| CFF Care Center & Pediatric Program SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| CFF Care Center New York Medical College | Valhalla | New York | 10595 | — |
| CFF Care Center & Pediatric Program University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| CFF Care Center & Pediatric Program Akron Children's Hospital | Akron | Ohio | 44308 | — |
| CFF Care Center & Pediatric Program Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| CFF Care Center & Pediatric Program Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | — |
| CFF Care Center & Pediatric Program Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| CFF Care Center & Pediatric Program The Children's Medical Center | Dayton | Ohio | 45404 | — |
| CFF Care Center & Pediatric Program Oregon Health & Sciences University | Portland | Oregon | 97239 | — |
| CFF Care Center & Pediatric Program Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| CFF Care Center & Pediatric Program Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| CFF Care Center & Pediatric Program Sanford USD Medical Center | Sioux Falls | South Dakota | 57117 | — |
| CFF Care Center & Pediatric Program University of Tennessee | Memphis | Tennessee | 38103 | — |
| CFF Care Center & Pediatric Program Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| CFF Care Center & Pediatric Program Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | — |
| CFF Care Center Medical College of Virginia | Richmond | Virginia | 23298 | — |
| CFF Care Center & Pediatric Program Seattle Children's Hospital | Seattle | Washington | 98145 | — |
| CFF Care Center & Pediatric Program University of Wisconsin | Madison | Wisconsin | 53792 | — |
| CFF Care Center & Pediatric Program Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
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 NCT02054156, 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 Oct 1, 2019 · Synced Oct 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02054156 live on ClinicalTrials.gov.