Skip to main content
OpenTrials
Completed

NCT Number: NCT01052961

A Study on Higher-dose Oseltamivir Treatment's Impact on Viral Clearance and Clinical Recovery in Adults Hospitalized With Influenza

Adult patients hospitalized with influenza have higher viral loads and more severe illnesses. Thus more aggressive treatment approaches (e.g. higher dose oseltamivir) have been suggested to treat patients suffering from severe influenza infection.

The investigators plan to investigate the impact of higher-dose oseltamivir (150 mg b.d.) treatment on viral clearance and clinical recovery in adult patients hospitalized for severe influenza. Such information may lead to optimization of the management strategy used for these patients.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Chinese University of Hong Kong, Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital

Hong Kong, Hksar

About this study

  • The investigators plan to study the impact of higher-dose oseltamivir (150 mg b.d.) treatment on rate of viral load decline and RNA negativity (in nasal and throat swabs, assessed by quantitative RT-PCR assay) and time to clinical recovery in adult patients hospitalized for severe influenza.
  • Patients who received intervention (oseltamivir 150 mg b.d. for 5 days) will be compared to those in the non-intervention arm (patients may receive oseltamivir treatment at 75 mg b.d. for 5 days, decided by their managing physicians) in the two respective study sites. Viral load changes and viral clearance will be compared. Clinical progress and time to symptom recovery will be reported. The protocol will be crossed-over to the other site at a defined time frame.
  • oseltamivir 150 mg b.d. has been shown to be safe and well-tolerated in earlier clinical trials
  • higher-dose treatment has been suggested by health authorities (e.g. WHO) to treat severe influenza infection/pneumonia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed influenza A (H1N1, H3N2) or B infection by IFA or RT-PCR, with a compatible clinical illness
  • presented within 96 hours from symptom onset
  • age >/= 18 years

Exclusion criteria

  • lack of consent
  • suspected avian influenza
  • patients who have received antivirals against influenza prior to admission
  • suspected or confirmed oseltamivir resistance
  • pre-existing renal impairment, with creatinine clearance <40 ml/min
  • pre-existing hepatic failure
  • participation in a clinical study involving experimental medication in the past 4 weeks
  • pregnant women, or who are attempting to become pregnant, or who are breast feeding.

Treatment and study plan

oseltamivir

Drug

oseltamivir 150 mg bd for 5 days

Primary outcomes

  1. rate of influenza virus load decline and viral RNA negativity upon receiving 5 days of study treatment

    Time frame: during and upon completion of the 5-day study treatment

Secondary outcomes

  1. time to clinical recovery (including symptoms, vital signs, hospital discharge)

    Time frame: during and upon completion of the 5-day study treatment

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Hoffmann-La Roche

Registry information

Official study title

Initiating Oseltamivir in Adults Hospitalized With Influenza -- a Study on the Impact of Virological Clearance and Clinical Recovery for Higher-dose Treatment Started Within 96 Hours

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 21, 2010
Registry last updated
Jul 20, 2012

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.

Published trials that share one or more normalized conditions with this study.