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 @ 2:22 AM
Ignite Modification Date:
2025-12-25 @ 2:22 AM
NCT ID:
NCT01037634
Eligibility Criteria:
Inclusion Criteria:
* Informed consent signed by a parent or legal guardian
* Younger than 12 months of age when first seen with a lower respiratory tract infection (LRTI)
* LRTI must be moderate or severe and influenza must be virologically proven by a respiratory specimen
* History of fever within 14 days prior to presentation (although fever at presentation is not required) plus any two of the following: cough, difficulty breathing or shortness of breath, increased respiratory rate for current age, intercostal recession, use of accessory muscles, nasal flare or grunting, crepitations with or without wheezing, a consistent abnormal chest x-ray (e.g., new infiltrate, hyperinflation)
* Virological evidence of influenza on any one of the tests specified in the protocol
Exclusion Criteria for Children with Non-Avian Influenza:
* Known allergy to oseltamivir
Additional Exclusion Criteria for Children with Non-Avian Influenza:
* Illness duration greater than 14 days on the day of hospital admission
* Creatinine clearance less than 10 mL/min/1.73m2, including a requirement for dialysis or hemofiltration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Month
Maximum Age:
12 Months
Study:
NCT01037634
Study Brief:
Protocol Section:
NCT01037634