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

• Status: Terminated
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital & Research Center Oakland; UCSF Benioff Children's Hospital Oakland
• Collaborator: Gilead Sciences
• Treatments: Aztreonam

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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