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

July 19, 2012 updated by: Nelson Lee, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • 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.

Study Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Non-intervention arm
patients may receive oseltamivir 75 mg bd for 5 days, decided by the managing physicians
ACTIVE_COMPARATOR: oseltamivir, higher dose
oseltamivir 150 mg bd for 5 days for patients presented within 96 hours from onset
Drug: Oseltamivir
oseltamivir 150 mg bd for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
during and upon completion of the 5-day study treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
time to clinical recovery (including symptoms, vital signs, hospital discharge)
Time Frame: during and upon completion of the 5-day study treatment
during and upon completion of the 5-day study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Hoffmann-La Roche

Investigators

  • Principal Investigator: Nelson LS Lee, MD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (ESTIMATE)

January 21, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CUHK 7010015, MV22926

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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