N/A N=75 Single-blind Diagnostic

Urease Breath Test for Rapid Characterization of Pneumonia

Pneumonia, Bacterial

Bottom Line

View on ClinicalTrials.gov: NCT03100760 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2025

Primary outcome: Primary: Adverse Events — 3; 0; 1; 0 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 13C-urea breath test (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of New Mexico
Primary completion: Jun 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Adverse Events	3; 0; 1; 0; 1; 0	—
PRIMARY Serious Adverse Events	0; 0	—
PRIMARY Suspected Adverse Reaction	0; 0	—
PRIMARY Serious Suspected Adverse Reaction	0; 0	—
SECONDARY Exhaled 13CO2 Concentration	1.3; 14.92	—
SECONDARY Number of Participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to Bacterial RNAseq Counts	0; 0	—
SECONDARY Number of Participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to CURB-65 Score in Urease-Positive Pneumonia	0; 0	—
SECONDARY Number of Participants With ¹³CO₂/¹²CO₂ Ratio Correlated (ρ > 0.75) to Pneumonia Severity Index in Urease-Positive Pneumonia.	0; 0	—
SECONDARY Number of Participants Meeting Sensitivity Criterion of ¹³C-Urea Breath Test for Urease-Producing Pathogens	0; 0	—
SECONDARY Number of Participants Meeting Specificity Criterion of ¹³C-Urea Breath Test for Urease-Producing Pathogens	0; 0	—
SECONDARY Number of Participants With Breath Test Positive and Confirmed Urease-Producing Pathogen (PPV Criterion)	0; 0	—
SECONDARY Number of Participants Meeting Negative Predictive Value Criterion of ¹³C-Urea Breath Test for Urease-Producing Pathogens	0; 0	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03100760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.