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 @ 7:37 PM
Ignite Modification Date:
2025-12-24 @ 7:37 PM
NCT ID:
NCT02960503
Eligibility Criteria:
Inclusion criteria:
1. Established diagnosis of sickle cell disease (HbSS, HbSC, HbS/β+, HbS/β0)
2. Age between 18-50 years
3. FEV1 \< 80% predicted
4. Willingness to make return visits and availability by telephone for the duration of the study.
Exclusion criteria:
1. Acute respiratory symptoms
2. FEV1\>80%
3. Inability to swallow pills
4. Hypersensitivity to macrolides.
5. History of cardiac arrhythmias
6. Prolonged QTc interval (\>500 ms) at on baseline EKG
7. Baseline impairment of hearing by pure tone audiometry defined as patients with age-adjusted hearing thresholds \>95th percentile at any one frequency of 500, 1000, 2000 and 4000 Hz.
8. The presence of a diagnosis other than SCD that results in the patient being medically unstable, or having a predicted life expectancy less than 1 year.
9. Special patient groups: prisoners, pregnant women, institutionalized patients
10. Women who are at risk of becoming pregnant during the study, and who refuse to use an acceptable means of birth control (hormonal based oral, intrauterine device or barrier contraception) for the duration of the study.
11. Patients taking tacrolimus, pimozide, disopyramide, cyclosporine, nelfinavir, bromocriptine, or hexobarbital.
12. Patients taking any medications that prolong QTc interval.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02960503
Study Brief:
Protocol Section:
NCT02960503