Urease Breath Test for Rapid Characterization of Pneumonia

June 24, 2025 updated by: Justin T Baca, University of New Mexico

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 1, open-label evaluation of an inhaled 13C-urea breath test in the identification of urease positive bacteria in patients diagnosed with pneumonia in the emergency department (ED). This study will enroll up to 75 adult male and female subjects in two cohorts. Adult subjects will be screened for participation in two dosing cohorts to be enrolled sequentially. Cohort A will enroll 15 subjects presenting to the ED with clinical concern for pneumonia and plan for outpatient treatment. Following enrollment and review of the safety of dosing in Cohort A, subjects receiving a diagnosis of pneumonia in the ED that are planned for admission will be screened for enrollment in Cohort B. Eligible subjects will provide informed consent, medical history, and samples for laboratory testing (including pregnancy testing for females of childbearing potential) during screening. Subjects will be evaluated for their CURB-65 Pneumonia Severity Score, and Community-Acquired Pneumonia Severity Index (PSI) where required data are available.

Prior to breath test administration, subjects will provide a sputum sample for bacterial culture; sample may be induced, or collected as part of initial ED workup if appropriate culture has been ordered. Subjects will undergo breath test with 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. Vital signs, including resting blood pressure, resting pulse, respiratory rate, peripheral oxygen saturation, and temperature will be collected prior to, and following completion of, nebulization treatment. In the event of bronchospasm, during or following nebulization, albuterol rescue will be available for treatment at the discretion of the investigator.

Once required tests are complete, the subject will be treated/followed according to standard institutional protocol/practice. The subjects' clinical course will be followed for at least 24 hours, where possible, to document the final diagnosis and outcome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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

    OR

    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

  2. be capable of providing a spontaneous or induced sputum sample for analysis
  3. be capable of completing the breath test according to the clinical judgement of the investigator
  4. be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent

Exclusion Criteria:

  1. have a known allergy to urea or any excipient in the nebulized solution
  2. be pregnant or have a positive urine pregnancy test
  3. have evidence of active oral infection, such as abscess or dense exudate, that requires antibiotic therapy
  4. have known diagnosis of cystic fibrosis or bronchiectasis
  5. have a known or suspected acute asthma exacerbation on presentation to the ED

  6. have received treatment with oral or intravenous (IV) antibiotics in the preceding 2 days prior to screening, unless antibiotic failure is suspected

    OR

    have received treatment in the ED with oral or IV antibiotics greater than 4 hours prior to breath test

  7. have an acute illness or other condition that, as determined by the investigator, would preclude participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study of Outpatient Treatment Cohort
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
Subjects will undergo 13C-urea breath test involving collection of baseline breath samples, nebulization of 13C-urea, and collection of post-nebulization breath samples
Experimental: Study of Inpatient Treatment Cohort
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
Subjects will undergo 13C-urea breath test involving collection of baseline breath samples, nebulization of 13C-urea, and collection of post-nebulization breath samples

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Within 24-48 hours of breath test
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
Time Frame: Within 24-48 hours of breath test
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
Time Frame: Within 24-48 hours of breath test
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
Time Frame: Within 24-48 hours of breath test
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exhaled 13CO2 Concentration
Time Frame: Collected at 6 minutes after nebulization and measured within 7 days of collection
We recorded change in 13CO2/12CO2 ratio (delta over baseline or ΔOB, in units of ‰) between pre- and post-nebulization samples
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
Time Frame: Collected at 6 minutes after nebulization and measured within 7 days of collection
We recorded change in 13CO2/12CO2 ratio (delta over baseline or ΔOB, in units of ‰) between pre- and post-nebulization samples and compared with subject's causative pathogen based upon sputum or blood culture results
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
Time Frame: 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.
Time Frame: 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
Time Frame: Collected at 6 minutes after nebulization and measured within 7 days of collection
This exploratory outcome was designed to assess whether the ¹³C-urea breath test (Δ¹³CO₂) is associated with the presence of urease-producing pathogens. Correlation between exhaled ¹³CO₂ levels and pathogen abundance (based on RNAseq bacterial counts) was to be evaluated using Spearman's correlation, with a pre-defined significance threshold of ρ > 0.75.
Collected at 6 minutes after nebulization and measured within 7 days of collection
Number of Participants Meeting Specificity Criterion of ¹³C-Urea Breath Test for Urease-Producing Pathogens
Time Frame: Collected at 6 minutes after nebulization and measured within 7 days of collection
This exploratory outcome was designed to assess the specificity of the ¹³C-urea breath test (Δ¹³CO₂) for detecting urease-producing pathogens. Specificity was defined as the proportion of participants without urease-producing pathogens (based on RNAseq bacterial profiles) who also did not meet the predefined breath test threshold. The planned analysis used Spearman correlation (ρ) between ¹³CO₂ enrichment and bacterial abundance, with ρ < 0.75 indicating a negative test result.
Collected at 6 minutes after nebulization and measured within 7 days of collection
Number of Participants With Breath Test Positive and Confirmed Urease-Producing Pathogen (PPV Criterion)
Time Frame: Collected at 6 minutes after nebulization and measured within 7 days of collection
This exploratory outcome measured the number of participants who met the criteria for positive predictive value of the ¹³C-urea breath test. A participant was considered to meet the PPV criterion if they had a positive breath test result (Spearman ρ > 0.75 between Δ¹³CO₂ and bacterial abundance) and also had RNAseq-confirmed presence of at least one urease-producing pathogen.
Collected at 6 minutes after nebulization and measured within 7 days of collection
Number of Participants Meeting Negative Predictive Value Criterion of ¹³C-Urea Breath Test for Urease-Producing Pathogens
Time Frame: Collected at 6 minutes after nebulization and measured within 7 days of collection
This exploratory outcome was designed to evaluate the number of participants meeting the negative predictive value (NPV) criterion of the ¹³C-urea breath test for detecting urease-producing pathogens. A participant was considered to meet the NPV criterion if they had a negative breath test result defined as a Spearman correlation coefficient (ρ) ≤ 0.75 between Δ¹³CO₂ and bacterial abundance and RNAseq-confirmed absence of urease-producing pathogens.
Collected at 6 minutes after nebulization and measured within 7 days of collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of New Mexico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Avisa Pharma Inc.
Malvern Consulting Group, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 4, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 4, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16-327

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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