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

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

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.

Study Overview

• Status: Terminated
• Conditions: Influenza; Upper Respiratory Tract Infection
• Intervention / Treatment: Drug: Oseltamivir; Drug: Zanamivir; Drug: Placebo of Oseltamivir

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China, 852
      • Shau Kei Wan Jockey Club Clinic
• Hong Kong
  • Hong Kong, Hong Kong
    • Fanling Family Medicine Centre
  • Hong Kong, Hong Kong
    • Sai Ying Pun Jockey Club General Outpatient Clinic

Participation Criteria

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oseltamivir	Drug: Oseltamivir; 75 mg twice daily for 5 days; Other Names: Tamiflu
Experimental: Zanamivir	Drug: Zanamivir; 10 mg twice daily for 5 days; Other Names: Relenza
Placebo Comparator: Placebo of Oseltamivir	Drug: Placebo of Oseltamivir; twice daily for 5 days; Other Names: Tamiflu Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to symptoms resolution as reported by the patient	one week

Secondary Outcome Measures

Outcome Measure	Time Frame
Treatment failure including hospitalization due to disease worsening.	one week
Viral load	one week
Severity of disease as measured by the patient diary and quality of life using SF12v2.	one week

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Collaborators: Food and Health Bureau, Hong Kong; Hospital Authority
• Investigators: Principal Investigator: Augustine T. LAM, MBBS, Prince of Wales Hospital, Shatin, Hong Kong

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: September 17, 2009
• First Submitted That Met QC Criteria: September 17, 2009
• First Posted (Estimate): September 18, 2009

Study Record Updates

• Last Update Posted (Estimate): April 11, 2011
• Last Update Submitted That Met QC Criteria: April 8, 2011
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Influenza A; Upper respiratory tract infection; Human Swine Influenza
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Orthomyxoviridae Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Zanamivir; Oseltamivir
• Other Study ID Numbers: CCT2009-CS-6