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

• Status: Terminated
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Collaborators: Food and Health Bureau, Hong Kong; Hospital Authority
• Treatments: Oseltamivir; Zanamivir

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