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 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 1:33 AM
NCT ID:
NCT02630394
Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of SCD (Hemoglobin SS, hemoglobin Sβ0 thalassemia)
* History of acute chest syndrome - the history of acute chest syndrome will be confirmed by a retrospective medical chart review that meets the standard definition as mentioned in the Background section.
* Age ≥ 6 years to 16 years old
Exclusion Criteria:
* Hemoglobin Sβ+thalassemia and hemoglobin SC subject will be excluded as this group of patients do not typically have severe SCD that places them at risk of developing recurrent acute chest syndrome
* No history of acute chest syndrome
* Significant neurologic impairment as judged by health care provider.
* Inability to take/swallow a tablet
* History of poor adherence to clinic visits.
* History of renal or hepatic dysfunction
* Chronic red blood cell transfusion
* History of allergy to azithromycin or macrolide antibiotic
* History of cardiac arrhythmia
* History of prolonged QT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
16 Years
Study:
NCT02630394
Study Brief:
Protocol Section:
NCT02630394