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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Nelson Lee, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01052961
First received: January 19, 2010
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza
Respiratory Tract Infections
 Drug: Oseltamivir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to clinical recovery (including symptoms, vital signs, hospital discharge) [ Time Frame: during and upon completion of the 5-day study treatment ] [ Designated as safety issue: No ]

Enrollment: 157
Study Start Date: January 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01052961

Locations
Hong Kong
The Chinese University of Hong Kong, Prince of Wales Hospital and Alice Ho Miu Ling Nethersole Hospital
Hong Kong, Hksar, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Hoffmann-La Roche
Investigators
Principal Investigator: Nelson LS Lee, MD Chinese University of Hong Kong
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Nelson Lee, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01052961     History of Changes
Other Study ID Numbers: CUHK 7010015, MV22926
Study First Received: January 19, 2010
Last Updated: July 19, 2012
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
severe influenza
hospitalized adults
oseltamivir treatment

Additional relevant MeSH terms:
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Infection
 Oseltamivir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013