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TERMINATEDPHASE3

Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria

Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization

NCT03219164•Gilead Sciences

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate the safety and efficacy of a 14-day course versus a 28-day course of aztreonam for inhalation solution (AZLI) in pediatric participants with new onset Pseudomonas aeruginosa respiratory tract infection or colonization.

Eligibility

Age

0 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosis of cystic fibrosis (CF) as determined by the 2008 CF Consensus Conference criteria: Sweat chloride level ≥ 60 milliequivalents per liter (mEq/L) by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more clinical features consistent with CF
•Documented new onset of positive respiratory tract culture for PA within 30 days of screening defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year)
•Forced expiratory volume in one second (FEV1) ≥ 80% predicted (for subjects ≥ 6 years of age who can reliably perform spirometry assessments)
•Clinically stable with no evidence of acute significant respiratory symptoms that would require administration of intravenous (IV) antipseudomonal antibiotics, oxygen supplementation, or hospitalization

Exclusion Criteria

•Use of IV or inhaled antipseudomonal antibiotics within 2 years of screening
•Use of oral antipseudomonal antibiotics for a respiratory event within 30 days of study entry (screening visit)
•History of intolerance to inhaled short acting β2 agonists
•History of lung transplantation
•Current requirement for daily continuous oxygen supplementation or requirement of more than 2 L/minute at night
•Hospitalization for a respiratory event within 30 days prior to screening
•Changes in bronchodilator, corticosteroid, dornase alfa, or hypertonic saline medications within 7 days prior to screening.
•Significant changes (per investigators discretion) in physiotherapy technique or schedule within 7 days prior to screening
•Abnormal renal or hepatic function results at most recent test within the previous 12 months, defined as Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit of normal (ULN), or Serum creatinine \> 2 times ULN for age
•Presence of a condition or abnormality that would compromise the subject's safety or the quality of the study data, in the opinion of the Investigator
+2 more criteria

Locations (53)

University of California San Francisco (UCSF) - Benioff Children's Hospital

San Francisco, California, United States

Children's National Health System

Washington D.C., District of Columbia, United States

Johns Hopkins All Children's Hospital Outpatient Care Center

St. Petersburg, Florida, United States

Ann & Robert H Lurie Childrens Hospital of Chicago

Chicago, Illinois, United States

Corner Children's Hospital

Chicago, Illinois, United States

University of Mississippi Medical center

Jackson, Mississippi, United States

Clinical Research of Charlotte

Charlotte, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

USC Department of Pediatrics/Division of Pediatric Pulmonology

Columbia, South Carolina, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Key Dates

Start Date

November 28, 2017

Primary Completion Date

May 27, 2020

Completion Date

September 23, 2021

Last Updated

June 14, 2022

Enrollment

149

ACTUAL participants

Conditions

Pseudomonas Aeruginosa Respiratory Tract Infection/ColonizationCystic Fibrosis

Interventions

AZLI

DRUG

Placebo

DRUG

Natural History of Noncirrhotic Portal Hypertension

NCT02417740

Cystic FibrosisImmunologic Deficiency Syndrome+3 more

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RECRUITINGNA

Personalized Mobile Health Platform to Promote Physical Activity in Adolescents and Young Adults With Cystic Fibrosis

NCT06616857

Cystic Fibrosis (CF)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 14, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Aztreonam for Inhalation in Children With Cystic Fibrosis and New Infection of the Airways by Pseudomonas Aeruginosa Bacteria

Inclusion Criteria

Exclusion Criteria

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