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:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-24 @ 11:57 PM
NCT ID:
NCT00235651
Eligibility Criteria:
Inclusion Criteria:
1. Single or double lung transplant recipients
2. Age \> 18
3. Willing to be available at the testing center
4. Able to understand and complete informed consent
Exclusion Criteria:
1. Pregnant women, or women capable of bearing children who will not perform urine pregnancy test.
2. Nursing mothers.
3. Hypersensitivity to amphotericin B (Abelcet®) or technetium \[Tc-99m\] based radiopharmaceuticals.
4. Subjects with a past history of bronchospasm associated with aerosol drug use
5. Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications
6. Subjects with an FEV1 \< 30% predicted or forced vital capacity (FVC) % predicted \< 30%
7. Subjects requiring supplemental oxygen
8. Receipt of inhalational or IV amphotericin B within last 30 days
9. Subjects with known fungal infection, as per Mycoses Study Group (MSG) criteria, on therapy with antifungal drugs or diagnosed on the day of bronchoscopy
10. Serum creatinine \> 1.9 mg/dl on the day of clinic visit
11. Liver enzymes ALT/AST/alk phos greater than two times the normal limit
12. Concurrent intravenous aminoglycoside use
13. Subjects with fever \> 38.2°C
14. Subjects on mechanical ventilation.
15. Have participated in any studies involving radiopharmaceuticals within 14 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00235651
Study Brief:
Protocol Section:
NCT00235651