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 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT01546935
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent by a parent/legal guardian.
* Children less than 12 months of age when first seen with a LRTI of moderate or severe severity and virologically proven influenza on a respiratory specimen.
* History of fever within 14 days prior to presentation (note: a fever at presentation is not required) plus any two of the following:
* Cough
* Difficulty breathing / shortness of breath
* Increased respiratory rate for that age:
* \> 60/min, age \< 2 months
* \> 50/min, age 2 - \< 12 months,
* Intercostal recession
* Use of accessory muscles
* Nasal flare/grunting
* Crepitations with or without wheezing
* A consistent abnormal chest X ray e.g. new infiltrate, hyperinflation
Virological evidence of influenza on the following test:
* A positive commercial rapid test confirmed twice for influenza on respiratory specimens from 2 different anatomical sites\*
\* Any one of the following constitutes an acceptable respiratory specimen:
* NPA
* NP swab
* throat swab
* endotracheal aspirate
* bronchoalveolar lavage sample
Exclusion Criteria:
Exclusion criteria for children with non avian influenza
These are:
* Known allergy to Oseltamivir
* Age ≥ 12 months on the day of hospital admission
* Illness duration \> 14 days on the day of hospital admission
* Creatinine clearance \< 10 mls/min/1.73m2, including a requirement for dialysis or haemofiltration Exclusion criteria for children with avian influenza
These are:
* Known allergy to Oseltamivir
* Age ≥ 12 months on the day of hospital admission
* Informed consent not obtained
Patients with the following can be enrolled:
* underlying illnesses
* if prescribed Oseltamivir prior to presentation
* for avian influenza only: creatinine clearance \< 10 mls/min/1.73m2, including a requirement for dialysis or haemofiltration
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
12 Months
Study:
NCT01546935
Study Brief:
Protocol Section:
NCT01546935