Oseltamivir for Influenza Lower Respiratory Tract Infection in Children Under One

NCT01546935 | Withdrawn Phase 2 DMC

• 1 other identifier: SEA022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Influenza

Keywords

Influenza; Oseltamivir; Lower tract respiratory infection

Outcome Measures

Primary Outcomes (2)

• Viral clearance

  * Viral clearance on Day 5 (human influenza) on a throat swab, assessed by RT PCR. * Viral clearance on Day 10 (avian influenza) on a throat swab, assessed by RT PCR.

  5-10 days

• Pharmacokinetics of Oseltamivir

  • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life

  Day 0 and Day 9

Secondary Outcomes (3)

• Viral end points

  5-10 days

• Clinical Efficacy Endpoints

  5-10 days

• Safety Endpoints

  5-10 days

Study Arms (1)

Oseltamivir

EXPERIMENTAL

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.

Drug: Oseltamivir

Interventions

Oseltamivir DRUG

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.

Also known as: Tamiflu

Oseltamivir

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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\*

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (2)

Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, 10400, Thailand

Location

Faculty of Medicine Siriraj Hospital

Bangkok, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Kulkanya Chokephaibulkit, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

• Piyarat Suntarattiwong, MD

  Queen Sirikit National Institute of Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 7, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 29, 2013

Record last verified: 2013-07

Locations

TH (2)