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Urease Breath Test for Rapid Characterization of Pneumonia

NCT03100760 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-07-14

Study results available
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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.

Conditions

  • Pneumonia, Bacterial

Interventions

DEVICE

13C-urea breath test

Subjects will undergo 13C-urea breath test involving collection of baseline breath samples, nebulization of 13C-urea, and collection of post-nebulization breath samples

Sponsors & Collaborators

  • Avisa Pharma Inc.

    collaborator UNKNOWN

  • Malvern Consulting Group, Inc.

    collaborator UNKNOWN

  • University of New Mexico

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2020-06-04
Completion
2020-06-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100760 on ClinicalTrials.gov