Influenza Clinical Trial
Official title:
SEA022 Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study.
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.
There are limited data from Thailand on the aetiology of LRTI but no data on mortality of
hospitalised children. Thai children < 1 year accounted for circa one third of LRTIs in
children who were treated as out or inpatients in whom influenza was isolated in 6 (2.7%) of
271 children and RSV in 44 (20%). At the Queen Sirikit hospital, Bangkok, influenza A and B
and RSV accounted for approximately 11% (9/80), 2.5% (2/80) and 6% (5/80) of children < 1
year, respectively. This study included children with underlying diseases like congenital
heart disease and chronic lung disease. A small laboratory series of 110 children at Siriraj
hospital with LRTIs infections (Pilaipan Puthavathana, personal communication) identified
RSV A/B (17%), metapneumovirus (14%), parainfluenza 1 (12%) and adenovirus (12%), influenza
B (6%), influenza A (4%), coronaviruses (3%), Parainfluenza 3 (2%) and 2 (0%).
The number of drugs registered for treating influenza is limited to oral Oseltamivir,
amantadine and rimantadine and inhaled zanamivir. As a result of the 2009 influenza A/H1N1,
clinical guidelines have been updated to include children less than one years old . However,
regulatory studies of oseltamivir excluded children under 1 year based on preclinical data
in rats in which there were deaths in young rats (7 days old) but none in 14 days old rats
given large doses of Oseltamivir. Higher concentrations of Oseltamivir were found in the
brains of the younger rats which was thought to be due immaturity of the blood brain
barrier.
There is, however, some clinical experience with Oseltamivir in the under ones from Japan,
Thailand, Germany , the USA , and additional experience with 2009 pH1N1 . The doses used
were 2 mg/kg bid which is consistent with the dose recommended in the UK for children who
weigh less than 15 kg (30 mg bid for 5 days). At the Queen Sirikit hospital, Oseltamivir has
been given to a very small number of children < 1 year with severe influenza with good
effect (T. Chotpitayasunondh, unpublished observations). This experience is similar to that
of others i.e. good clinical outcomes and apparently good tolerability.
An Oseltamivir pharmacokinetic study in children age 1-5 years showed that the dose of 2
mg/kg resulted in plasma-concentration time curves (AUC) similar to the AUC accepted in
adult. However, the younger the child, the lower the AUC level; never the less, there are
still insufficient pharmacokinetics data in children under one year .
The clinical significance of reduced in vitro sensitivity is unclear owing to the paucity of
human data but these mutations are likely to result in reduced antiviral efficacy of
Oseltamivir and the adamantanes against H1N1. Furthermore, amantadine treatment of influenza
frequently results in the rapid development of amantadine resistance in both H1N1 and H2N3
viruses, resulting in continued virus replication, thus, making this drug less than ideal
for treating influenza. Currently, there is limited adamantane resistant H1N1 but widespread
adamantane resistant in H3N2. H3N2 and influenza B remain sensitive to Oseltamivir. The
adamantanes have no activity against influenza B.
The emergence of resistance poses difficulties for the treatment of influenza in children
less than one but oseltamivir represents at present the optimal choice for treating such
children. Therefore, this protocol will assess the effect of oral Oseltamivir at doses
recommended by the WHO to see if they are applicable to Thai children.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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