A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection

This study has been terminated.
(Decreased Influenza activity; thus decrease/no eligible patient to recruit)
Sponsor:
Collaborators:
Food and Health Bureau, Hong Kong
Hospital Authority
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00979667
First received: September 17, 2009
Last updated: April 8, 2011
Last verified: May 2010
  Purpose

To evaluate the efficacy of oseltamivir ,as compared with the placebo arm and zanamivir with its control arm with respect to symptoms duration among patients infected with influenza A (H1N1) virus.


Condition Intervention Phase
Upper Respiratory Tract Infection
Influenza
Drug: Oseltamivir
Drug: Zanamivir
Drug: Placebo of Oseltamivir
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Randomized, Controlled Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As The First Line Treatment For Human Swine Influenza (H1N1) Infection In Designated Flu Clinics During The Pandemic Influenza in Hong Kong

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Time to symptoms resolution as reported by the patient [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment failure including hospitalization due to disease worsening. [ Time Frame: one week ] [ Designated as safety issue: Yes ]
  • Viral load [ Time Frame: one week ] [ Designated as safety issue: Yes ]
  • Severity of disease as measured by the patient diary and quality of life using SF12v2. [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Enrollment: 4
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oseltamivir Drug: Oseltamivir
75 mg twice daily for 5 days
Other Name: Tamiflu
Experimental: Zanamivir Drug: Zanamivir
10 mg twice daily for 5 days
Other Name: Relenza
Placebo Comparator: Placebo of Oseltamivir Drug: Placebo of Oseltamivir
twice daily for 5 days
Other Name: Tamiflu Placebo

Detailed Description:

The outbreak of respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.

The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This study is to test the oseltamivir, zanamivir and placebo arms as the first line treatment for human swine influenza infection. Through the study, the investigators may have better understanding about the clinical and, biochemical, virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment strategy among the Chinese population.

  Eligibility

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

Inclusion Criteria:

  • Male or female patients 18 years or older with body weight >40kg
  • Written informed consent
  • Presented within 48 hours of onset of influenza-like illness
  • Presumptive diagnosis of H1N1 satisfying the following clinical and laboratory criteria:

    • Clinical criteria

      • Fever >38 oC (Infrared Forehead Thermometer will be used to measure the Temporal Artery Temperature under the skin) AND
      • At least one upper respiratory tract infection (cough, running nose, sore throat)
    • Laboratory criteria Positive rapid test result for influenza A (by Influenza Rapid Diagnostic test) within 48 hours of onset of flu-like symptoms

Exclusion Criteria:

  • Age below 18 years
  • Persons who lack the ability to care for themselves
  • Patient with critical condition or already developed severe respiratory distress with hypoxaemia on presentation
  • Pregnancy or lactation
  • Coexisting liver disease
  • Coexisting cardiovascular disease except stable hypertension without complication
  • Coexisting chronic pulmonary disease
  • Coexisting immuno-compromised medical conditions or on concurrent immunosuppressive therapies
  • Renal failure
  • Terminal malignancies or terminal end-organ failure with an estimated life-expectancy of less than 3 months
  • Known intolerance to oseltamivir or zanamivir
  • Known history of significant neurological disorders that can compromise respiratory function or the handling of respiratory secretions or that can increase the risk for aspiration or those
  • Subjects who have received oseltamivir as prophylaxis for H1N1 infection
  • Subjects who have received any investigational drug within 1 month prior to study entry
  • Subjects with a mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979667

Locations
China, Hong Kong
Shau Kei Wan Jockey Club Clinic
Hong Kong, Hong Kong, China, 852
Hong Kong
Fanling Family Medicine Centre
Hong Kong, Hong Kong
Sai Ying Pun Jockey Club General Outpatient Clinic
Hong Kong, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
Food and Health Bureau, Hong Kong
Hospital Authority
Investigators
Principal Investigator: Augustine T. LAM, MBBS Prince of Wales Hospital, Shatin, Hong Kong
  More Information

No publications provided

Responsible Party: Prof. Benny Chung Ying ZEE and Dr. Augustine Tsan LAM, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00979667     History of Changes
Other Study ID Numbers: CCT2009-CS-6
Study First Received: September 17, 2009
Last Updated: April 8, 2011
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
Upper respiratory tract infection
Influenza A
Human Swine Influenza

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

ClinicalTrials.gov processed this record on April 23, 2014