Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One
Influenza
About this trial
This is an interventional treatment trial for Influenza focused on measuring Influenza, Oseltamivir, Lower tract respiratory infection
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
Sites / Locations
- Queen Sirikit National Institute of Child Health
- Faculty of Medicine Siriraj Hospital
Arms of the Study
Arm 1
Experimental
Oseltamivir
The dose of Oseltamivir will be 3 mg/kg 12 hourly for 5 days (seasonal influenza and 2009 H1N1) or 10 days (avian influenza) for children whose renal function is ≥ 30 mls/min/1.73m2.