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 @ 5:28 PM
Ignite Modification Date:
2025-12-24 @ 5:28 PM
NCT ID:
NCT00391768
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent from parent(s) or legal guardian(s).
* Age:
Cohort I: 12 - 23 mo. Cohort II: 9 - 11 mo. Cohort III: 6 - 8 mo. Cohort IV: 3 - 5 mo. Cohort V: 0 - 2 mo.
* Confirmed laboratory diagnosis of influenza by viral culture or rapid influenza diagnostic test within 96 hours prior to study enrollment.
* Duration of influenza symptoms less than or equal to 96 hours.
Exclusion Criteria:
* Concomitant vomiting illness that would preclude ability to take drug.
* Immunocompromised subject (e.g., malignancy, congenital agammaglobulinemia, HIV).
* Documented renal impairment (e.g., polycystic renal disease, nephrectomy, renal transplantation, renal agenesis, dialysis requirement, renal failure, nephrotic syndrome at any time prior to enrollment, current receipt of diuretic therapy).
* Documented hepatic impairment (e.g., congenital hepatitis, biliary atresia, cholelithiasis).
* Gastrointestinal abnormality which might hinder absorption of an oral medication.
* Current receipt of inotropic drugs (e.g., epinephrine, norepinephrine, dopamine, dobutamine).
* History of seizures.
* Documented congenital malformations of the central nervous system defined at birth (e.g., hydranencephaly, prosencephaly, spina bifida).
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
23 Months
Study:
NCT00391768
Study Brief:
Protocol Section:
NCT00391768