Urease Breath Test for Rapid Characterization of Pneumonia

NCT03100760 | Completed Results DMC

• 1 other identifier: 16-327
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

urease; Point-of-Care; Breath test

Outcome Measures

Primary Outcomes (4)

• Adverse Events

  Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

  Within 24-48 hours of breath test

• Serious Adverse Events

  Death, disability, incapacitation, escalation of level of care, prolongation of hospitalization, birth defect, or intervention to prevent the above.

  Within 24-48 hours of breath test

• Suspected Adverse Reaction

  Any adverse event for which there is a reasonable possibility that the adverse event was caused by the study drug.

  Within 24-48 hours of breath test

• Serious Suspected Adverse Reaction

  Any Suspected Adverse Reaction that is determined to be serious, based on the outcomes of a Serious Adverse Event; i.e. death, life-threatening, causes or prolongs inpatient hospitalization, causes a persistent of significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital abnormality/birth defect.

  Within 24-48 hours of breath test

Secondary Outcomes (8)

• Exhaled 13CO2 Concentration

  Collected at 6 minutes after nebulization and measured within 7 days of collection

• Number of Participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to Bacterial RNAseq Counts

  Collected at 6 minutes after nebulization and measured within 7 days of collection

• Number of Participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to CURB-65 Score in Urease-Positive Pneumonia

  Collected at 6 minutes after nebulization and measured within 7 days of collection

• Number of Participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to Pneumonia Severity Index in Urease-Positive Pneumonia.

  Collected at 6 minutes after nebulization and measured within 7 days of collection

• Number of Participants Meeting Sensitivity Criterion of ¹³C-Urea Breath Test for Urease-Producing Pathogens

  Collected at 6 minutes after nebulization and measured within 7 days of collection

Study Arms (2)

Study of Outpatient Treatment Cohort

EXPERIMENTAL

Subjects presenting to the emergency department with clinical suspicion for bacterial pneumonia and plan for outpatient treatment will undergo collection of baseline breath samples (up to 6), followed by complete nebulization of 13C-urea solution. Immediately following the end of nebulization, breath collection bag samples will be collected at up to 6 time points with at least 1 minute intervals within 10 minutes post-nebulization. Exhaled breath bags will be centrally processed to determine the change in exhaled 13CO2 levels.

Device: 13C-urea breath test

Study of Inpatient Treatment Cohort

EXPERIMENTAL

Subjects presenting to the emergency department with clinical suspicion for bacterial pneumonia and plan for inpatient treatment will undergo collection of baseline breath samples (up to 6), followed by complete nebulization of 13C-urea solution. Immediately following the end of nebulization, breath collection bag samples will be collected at up to 6 time points with at least 1 minute intervals within 10 minutes post-nebulization. Exhaled breath bags will be centrally processed to determine the change in exhaled 13CO2 levels.

Device: 13C-urea breath test

Interventions

13C-urea breath test DEVICE

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

Study of Inpatient Treatment Cohort; Study of Outpatient Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohort A Only: be a man or woman age 18-65, inclusive, with suspected bacterial pneumonia on presentation to the ED based on clinical signs and symptoms AND be planned for outpatient treatment
• Cohort B Only: be a man or woman age 18-85, inclusive, with a diagnosis of suspected bacterial pneumonia in the ED based on findings of a positive chest x-ray and clinical signs and symptoms AND be planned for admission to the hospital ward/floor
• be capable of providing a spontaneous or induced sputum sample for analysis
• be capable of completing the breath test according to the clinical judgement of the investigator
• be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent

You may not qualify if:

• have a known allergy to urea or any excipient in the nebulized solution
• be pregnant or have a positive urine pregnancy test
• have evidence of active oral infection, such as abscess or dense exudate, that requires antibiotic therapy
• have known diagnosis of cystic fibrosis or bronchiectasis
• have a known or suspected acute asthma exacerbation on presentation to the ED
• have received treatment with oral or intravenous (IV) antibiotics in the preceding 2 days prior to screening, unless antibiotic failure is suspected
• have received treatment in the ED with oral or IV antibiotics greater than 4 hours prior to breath test
• have an acute illness or other condition that, as determined by the investigator, would preclude participation in the study

Sponsors & Collaborators

• University of New Mexico: lead
• Avisa Pharma Inc.: collaborator
• Malvern Consulting Group, Inc.: collaborator

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Pneumonia, Bacterial

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

Small sample size, observational design, and limited follow-up period may limit generalizability. Study was primarily designed to assess safety and feasibility, not diagnostic efficacy.

Results Point of Contact

• Title: Justin Baca
• Organization: University of New Mexico Health Sciences Center

jtbaca@salud.unm.edu

505-272-5062

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Care Providers will not be provided with the results of the breath test, and will treat patients according to the current standards of care
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Emergency Medicine

Model Details: Open label evaluation of breath test for safety and detection of urease producing pathogens in two cohorts of emergency department patients with suspected bacterial pneumonia.

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: April 4, 2017
• Study Start: May 1, 2017
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: July 14, 2025
• Results First Posted: July 14, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)