CompletedNot Applicable

Urease Breath Test for Rapid Characterization of Pneumonia

United States75 participantsStarted 2017-05-01

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse Events

Timeframe: Within 24-48 hours of breath test

Serious Adverse Events

Timeframe: Within 24-48 hours of breath test

Suspected Adverse Reaction

Timeframe: Within 24-48 hours of breath test

Serious Suspected Adverse Reaction

Timeframe: Within 24-48 hours of breath test

Trial details

NCT IDNCT03100760

SponsorUniversity of New Mexico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-04

Results submitted2025-04-29

View on ClinicalTrials.gov More Pneumonia, Bacterial trials

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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
. 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