Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One

• Status: Withdrawn
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one.

There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Treatments: Oseltamivir

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