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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00979667
Recruitment Status : Terminated (Decreased Influenza activity; thus decrease/no eligible patient to recruit)
First Posted : September 18, 2009
Last Update Posted : April 11, 2011
Sponsor:
Collaborators:
Food and Health Bureau, Hong Kong
Hospital Authority
Information provided by:
Chinese University of Hong Kong

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Upper Respiratory Tract Infection Influenza Drug: Oseltamivir Drug: Zanamivir Drug: Placebo of Oseltamivir Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : October 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Time to symptoms resolution as reported by the patient [ Time Frame: one week ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979667


Locations
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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
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Principal Investigator: Augustine T. LAM, MBBS Prince of Wales Hospital, Shatin, Hong Kong
More Information
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Responsible Party: Prof. Benny Chung Ying ZEE and Dr. Augustine Tsan LAM, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00979667    
Other Study ID Numbers: CCT2009-CS-6
First Posted: September 18, 2009    Key Record Dates
Last Update Posted: April 11, 2011
Last Verified: May 2010
Keywords provided by Chinese University of Hong Kong:
Upper respiratory tract infection
Influenza A
Human Swine Influenza
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
Disease Attributes
Pathologic Processes
RNA Virus Infections
 Virus Diseases
Respiratory Tract Diseases
Oseltamivir
Zanamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action