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OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis

NCT02054156 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 221

Last updated 2019-10-01

Study results available
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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

Interventions

DRUG

azithromycin

3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months

DRUG

placebo

3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months

DRUG

Tobramycin solution for inhalation

300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Bonnie Ramsey

    lead OTHER

Principal Investigators

  • Bonnie Ramsey, MD · Seattle Children's Center for Clinical and Translational Research, CF Therapeutics Development Network Clinical Coordinating Center

  • Nicole Hamblett, PhD · Seattle Children's Core for Biomedical Statistics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-08-23
Completion
2018-08-23

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02054156 on ClinicalTrials.gov