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Completed

NCT Number: NCT00949533

A Study on Emergence of Resistance With Oseltamivir (Tamiflu) in Participants With Seasonal Influenza

This open-label randomized 2 arm study will determine the emergence of viral resistance in participants with seasonal influenza A infection treated with oseltamivir. Eligible participants less than or equal to (</=) 5 years of age will be randomized to receive oseltamivir at either standard dose (30-75 milligrams [mg] orally twice daily [bid]) or double dose (60-150 mg orally bid) for 5 days. Target sample size is greater than (>) 100.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Curitiba, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • positive rapid antigen test for influenza A
  • onset of symptoms of influenza (fever, at least one respiratory symptom) </=48 hours

Exclusion criteria

  • clinical suspicion of infection with a respiratory virus other than influenza
  • suspicion of invasive bacterial infection
  • evidence of poorly controlled underlying disease
  • known immunosuppression
  • known allergy to Oseltamivir
  • women who are pregnant or planning to get pregnant during the study

Treatment and study plan

oseltamivir

Drug

Standard dose (30 - 75 mg orally bid) or double dose (60 - 150 mg orally bid); for 5 days

Other names: Tamiflu

Primary outcomes

  1. Percentage of Participants Excreting Resistant Virus

    Time frame: Day 5

    Resistant virus included new influenza A virus subtype hemagglutinin type 1 and neuraminidase type 1 (New AH1N1).

Secondary outcomes

  1. Percentage of Participants With A Reduction in Viral Load

    Time frame: Baseline, Day 5

    Viral load is defined as the amount of H1N1 virus in blood. As per investigator, a participant was considered as having viral load reduction at Day 5 if the Day 5 viral load was lower than the Baseline viral load.

  2. Number of Participants With Various Clinical Signs and Symptoms

    Time frame: Day 5

    Number of participants with various clinical signs and symptoms, as per investigator's discretion, were reported. Same participants were reported in more than 1 category. "Other" in the category included abdominal pain, breathlessness, thoracic pain and tired.

  3. Number of Participants With Various Clinical Signs and Symptoms in Whom Resistant Virus Were Detected

    Time frame: Day 5

    Number of participants with various clinical signs and symptoms, as per investigator's discretion, in whom new AH1N1 virus was detected, were reported. Same participants were reported in more than 1 category.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Phase IIIb, Open-label, Comparative, Randomized Study on Resistance of Influenza A/H1N1 2009 Virus to Treatment With Oseltamivir at Standard Dose Versus Double Dose

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 30, 2009
Registry last updated
Aug 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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