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The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas

NCT03158116 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-07-30

Study results available
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Summary

This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa. The aim of the study is to see if AZLI being taken in a one month on / one month off cycle over the course of a year can decrease the need for systemic antibiotics and/or hospitalizations.

Conditions

  • Tracheostomy Infection

Interventions

DRUG

Inhaled Aztreonam

Inhaled antibiotic with anti-pseudomonal properties

Sponsors & Collaborators

  • Gilead Sciences

    collaborator INDUSTRY

  • UCSF Benioff Children's Hospital Oakland

    lead OTHER

Principal Investigators

  • Rachna Wadia, MD · UCSF Benioff Children's Hospital Oakland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2020-02-20
Completion
2020-02-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03158116 on ClinicalTrials.gov