Clinical trialNCT02054156CompletedPhase 3Interventional

OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

SponsorBonnie RamseyEnrollment221Cystic Fibrosis

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Bonnie Ramsey, MD
Seattle Children's Center for Clinical and Translational Research, CF Therapeutics Development Network Clinical Coordinating Center
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Nicole Hamblett, PhD
Seattle Children's Core for Biomedical Statistics
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

45 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Cff Affiliate Program Providence Medical Center
Anchorage, Alaska, United States
Cff Care Center Arizona Health Science Center
Tucson, Arizona, United States
Cff Care Center & Pediatric Program Arkansas Children'S Hospital
Little Rock, Arkansas, United States
Childrens Hospital Los Angeles
Los Angeles, California, United States
Cff Care Center & Pediatric Program Stanford University
Palo Alto, California, United States
Cff Care Center & Pediatric Program Children'S Hospital Colorado
Aurora, Colorado, United States
Cff Care Center & Pediatric Program Yale University
New Haven, Connecticut, United States
Cff Care Center & Pediatric Program Nemours Children'S Clinic - Jacksonville
Jacksonville, Florida, United States
Cff Care Center & Pediatric Program All Children'S Hospital
St. Petersburg, Florida, United States
Cff Affiliate Program Children'S Healthcare of Atlanta
Atlanta, Georgia, United States
Cff Care Center & Pediatric Program Emory University
Atlanta, Georgia, United States
Cff Care Center St. Luke'S Cf Clinic
Boise, Idaho, United States
Cff Care Center & Pediatric Program Ann & Robert H. Lurie Children'S Hospital of Chicago
Chicago, Illinois, United States
Cff Care Center & Pediatric Program Riley Hospital for Children
Indianapolis, Indiana, United States
Cff Care Center & Pediatric Program University of Iowa
Iowa City, Iowa, United States
Cff Care Center & Pediatric Program Maine Medical Center
Portland, Maine, United States
Cff Care Center & Pediatric Program Children'S Hospital Boston
Boston, Massachusetts, United States
Cff Care Center & Pediatric Program University of Michigan
Ann Arbor, Michigan, United States
Cff Care Center & Pediatric Program Children'S Hospital of Michigan
Detroit, Michigan, United States
Cff Care Center the Children'S Mercy Hospital
Kansas City, Missouri, United States
Cff Care Center & Pediatric Program Cardinal Glennon Children'S Hospital/saint Louis University
St Louis, Missouri, United States
Cff Care Center & Pediatric Program St. Louis Children'S Hospital
St Louis, Missouri, United States
Cff Care Center & Pediatric Program University of Nebraska Medical Center
Omaha, Nebraska, United States
Cff Care Center & Pediatric Program Monmouth Medical Center
Long Branch, New Jersey, United States
Cff Care Center & Pediatric Program Columbia University
New York, New York, United States
Cff Care Center & Pediatric Program Suny Upstate Medical University
Syracuse, New York, United States
Cff Care Center New York Medical College
Valhalla, New York, United States
Cff Care Center & Pediatric Program University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Cff Care Center & Pediatric Program Akron Children'S Hospital
Akron, Ohio, United States
Cff Care Center & Pediatric Program Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Cff Care Center & Pediatric Program Rainbow Babies and Children'S Hospital
Cleveland, Ohio, United States
Cff Care Center & Pediatric Program Nationwide Children'S Hospital
Columbus, Ohio, United States
Cff Care Center & Pediatric Program the Children'S Medical Center
Dayton, Ohio, United States
Cff Care Center & Pediatric Program Oregon Health & Sciences University
Portland, Oregon, United States
Cff Care Center & Pediatric Program Hershey Medical Center
Hershey, Pennsylvania, United States
Cff Care Center & Pediatric Program Children'S Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Cff Care Center & Pediatric Program Sanford Usd Medical Center
Sioux Falls, South Dakota, United States
Cff Care Center & Pediatric Program University of Tennessee
Memphis, Tennessee, United States
Cff Care Center & Pediatric Program Dell Children'S Medical Center of Central Texas
Austin, Texas, United States
University of Utah
Salt Lake City, Utah, United States

5 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Tobramycin solution for inhalationAzithromycin →Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2014
Primary completion: 23 Aug 2018
Completion: 23 Aug 2018
Last update posted: 1 Oct 2019
Registered enrollment: 221
Registry id: NCT02054156

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.