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 range18 Years – 85 Years

SexALL

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

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 range18 Years – 85 Years

SexALL

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