Pneumonia, BacterialNCT03100760
Urease Breath Test for Rapid Characterization of Pneumonia
A study testing 13C-urea breath test in people with Pneumonia, Bacterial, run by University of New Mexico at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pneumonia, Bacterial
- What is being tested?
- 13C-urea breath test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 4 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 9Show fewer
- OR
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia, Bacterial
- Being tested
- 13C-urea breath test
- Keywords
- urease, Point-of-Care, Breath test
- Medical subject headings
- Pneumonia, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 13C-urea breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 24-48 hours of breath test
Secondary outcomes (8)
Exhaled 13CO2 Concentration
We recorded change in 13CO2/12CO2 ratio (delta over baseline or ΔOB, in units of ‰) between pre- and post-nebulization samples
Measured: 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
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
Measured: 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
Number of participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to CURB-65 Score in Urease-Positive Pneumonia
Measured: 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.
Number of Participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to Pneumonia Severity Index in Urease-Positive Pneumonia.
Measured: 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
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 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
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.
Measured: Collected at 6 minutes after nebulization and measured within 7 days of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 May 2017
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pneumonia, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Avisa Pharma Inc., Malvern Consulting Group, Inc.
- Responsible party
- Principal investigator, Justin T Baca, University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100760
- Sponsor's protocol ID
- 16-327
- Status last verified
- Jun 2025
- First submitted
- 20 Mar 2017
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03100760
- Acronym / sponsor ID
- 16-327
- Conditions
- Pneumonia, Bacterial
- Keywords
- urease, Point-of-Care, Breath test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Avisa Pharma Inc., Malvern Consulting Group, Inc.
- Study start
- 1 May 2017 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study of Outpatient Treatment Cohort | Experimental | Device: 13C-urea breath testSubjects 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. |
| Study of Inpatient Treatment Cohort | Experimental | Device: 13C-urea breath testSubjects 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C-urea breath testSubjects will undergo 13C-urea breath test involving collection of baseline breath samples, nebulization of 13C-urea, and collection of post-nebulization breath samples | Device | Study of Inpatient Treatment Cohort, Study of Outpatient Treatment Cohort |
Primary outcome
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.
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.
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.
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.
8 secondary outcomes
Exhaled 13CO2 Concentration
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 Bacterial RNAseq Counts
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
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.
Time frame: 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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 13C-urea breath test in people with Pneumonia, Bacterial, run by University of New Mexico at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Within 24-48 hours of breath test). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.