At a glance
ClinicalIndex Comparison RecordN/ACompleted· 75 enrolled
Drug / intervention
13C-urea breath testdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Open-label, Evaluation of a 13C-urea Breath Test for the Detection of Urease-producing Bacteria in Patients Diagnosed With Pneumonia in the Emergency Department
In Brief
A clinical study evaluating 13C-urea breath test for Pneumonia, Bacterial. Completed, enrolled 75 participants across 1 site.
Detailed Summary
This is a Phase 1, open label, evaluation of a 13C-urea breath test for the detection of urease-producing bacteria in patient with pneumonia in the emergency department.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPneumonia, Bacterial
CountriesUnited States
CollaboratorsAvisa Pharma Inc., Malvern Consulting Group, Inc.
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedApr 2017
Enrollment StartMay 2017
Primary CompletionJun 2020
TodayJul 2026
First PostedApr 4, 2017
Enrollment StartMay 1, 2017
Primary CompletionJun 4, 2020
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 9.2 years ago
Interventions
13C-urea breath testdevice
Subjects will undergo 13C-urea breath test involving collection of baseline breath samples, nebulization of 13C-urea, and collection of post-nebulization breath samples