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

Stopped early · Phase 4

Conditions studied: Tracheostomy Infection

In brief

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.

Key facts

Study ID

NCT03158116

Run by

UCSF Benioff Children's Hospital Oakland

People needed

5

Starts

2017-07-01

Expected to finish

2020-02-20

Last updated by the study team

2021-07-30

Who can join

Age: 7 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• o Age: 7 - 21 years old
• Currently has a tracheostomy tube
• One of previous 3 tracheostomy tube aspirate cultures positive for Pseudomonas aeruginosa
• Non-smoker
• Ability of parent to provide informed consent, as evidenced by signing a copy of the consent form approved by the Institutional Review Board of the subject's respective study institution.
• Written assent for children 7-17 years of age.
• Informed consent for children ages 18-21, as evidence by signing a copy of the consent form approved by the Institutional Review Board of the subject's respective study institution.

You may not qualify if…

• o History of immunodeficiency
• History of cystic fibrosis. Primary ciliary dyskinesia, or bronchiectasis
• History of tuberculosis
• History of positive culture for Burkholderia cepacia
• Use of inhaled antibiotics in the last 6 months

Where it is running

• Benioff Children's Hospital Oakland — Oakland, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.