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NCT03158116 · ClinicalTrials.gov registry record · Phase 4
The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas
A Phase 4 study, sponsored by UCSF Benioff Children's Hospital Oakland.
- Terminated
- Registry status
- Phase 4
- Development phase
- 5
- Enrollment target
NCT03158116: Clinical Trial Phase 4 study, sponsored by UCSF Benioff Children's Hospital Oakland.
NCT03158116 is a Phase 4 study that was terminated before completion, run by UCSF Benioff Children's Hospital Oakland. The registered enrollment target is 5 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03158116, a Phase 4 study, was terminated before completion, sponsored by UCSF Benioff Children's Hospital Oakland.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with a reduced number of days of systemic antibiotics needed after participant starts using the study drug. (compare 1 year prior to starting study drug to the 1 year while patient is on the study drug)
Interventions
- DRUG Inhaled Aztreonam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-07-01 |
| Est. Completion | 2020-02-20 |
| Phase | Phase 4 |
Why NCT03158116 stopped before completion
NCT03158116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Inhaled Aztreonam is the first listed.
NCT03158116 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03158116 about?
NCT03158116 is a clinical study titled "The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas". 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 th...
What is the current status of trial NCT03158116?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 5 participants. The study started on 2017-07-01. Estimated completion is 2020-02-20.
What interventions are being tested in trial NCT03158116?
The interventions under investigation include: Inhaled Aztreonam (DRUG).
Who is sponsoring clinical trial NCT03158116?
This trial is sponsored by UCSF Benioff Children's Hospital Oakland, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03158116's enrollment target sits among peer trials
5 1989th of 2000 higher than 7 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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