Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03100760
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT03100760
Study Brief:
Protocol Section:
NCT03100760