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

NCT03219164 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2022-06-14

Study results available
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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.

Conditions

  • Pseudomonas Aeruginosa Respiratory Tract Infection/Colonization
  • Cystic Fibrosis

Interventions

DRUG

AZLI

Administered via the PARI Altera® Nebulizer System. Participants \< 2 years will receive via the SmartMask® Baby, 2 to \< 6 years via the SmartMask Kids® and \> 6 years via the nebulizer mouthpiece.

DRUG

Placebo

Administered via the PARI Altera® Nebulizer System. Participants \< 2 years will receive via the SmartMask® Baby, 2 to \< 6 years via the SmartMask Kids® and \> 6 years via the nebulizer mouthpiece.

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-11-28
Primary Completion
2020-05-27
Completion
2021-09-23
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Denmark
  • France
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT03219164 on ClinicalTrials.gov