Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

NCT02054156 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DRUG placebo
  • DRUG azithromycin
  • DRUG Tobramycin solution for inhalation

Study Locations (20)

California

  • Childrens Hospital Los Angeles — Los Angeles
  • CFF Care Center & Pediatric Program Stanford University — Palo Alto

Florida

  • CFF Care Center & Pediatric Program Nemours Children's Clinic - Jacksonville — Jacksonville
  • CFF Care Center & Pediatric Program All Children's Hospital — St. Petersburg

Georgia

  • CFF Care Center & Pediatric Program Emory University — Atlanta
  • CFF Affiliate Program Children's Healthcare of Atlanta — Atlanta

Michigan

  • CFF Care Center & Pediatric Program University of Michigan — Ann Arbor
  • CFF Care Center & Pediatric Program Children's Hospital of Michigan — Detroit

Alaska

  • CFF Affiliate Program Providence Medical Center — Anchorage

Arizona

  • CFF Care Center Arizona Health Science Center — Tucson

Arkansas

  • CFF Care Center & Pediatric Program Arkansas Children's Hospital — Little Rock

Colorado

  • CFF Care Center & Pediatric Program Children's Hospital Colorado — Aurora

Trial Details

FieldValue
Enrollment Target 221 participants
Start Date 2014-06
Est. Completion 2018-08-23
Phase Phase 3

Sponsor

Bonnie Ramsey

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02054156

The ClinicalTrials.gov registry entry for NCT02054156 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bonnie Ramsey, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 3 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02054156 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02054156 about?

NCT02054156 is a clinical study titled "OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis". 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 b...

What is the current status of trial NCT02054156?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 221 participants. The study started on 2014-06. Estimated completion is 2018-08-23.

What conditions does trial NCT02054156 study?

This clinical trial studies the following conditions: Cystic Fibrosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02054156?

The interventions under investigation include: placebo (DRUG), azithromycin (DRUG), Tobramycin solution for inhalation (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02054156?

This trial is sponsored by Bonnie Ramsey, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02054156 being conducted?

This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial