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 range

7 Years – 21 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Tracheostomy Infection trials