TerminatedPhase 4

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

Stopped: IRB application expired.

United States5 participantsStarted 2017-07-01

Plain-language 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.

Who can participate

Age range7 Years – 21 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants With a Decreased Need for Systemic Antibiotics While on the Study Drug

Timeframe: 1 year

Trial details

NCT IDNCT03158116

SponsorUCSF Benioff Children's Hospital Oakland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-20

Results submitted2021-07-09