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

The Chinese University of Hong Kong

Status and phase

Terminated

Phase 3

Conditions

Influenza

Upper Respiratory Tract Infection

Treatments

Drug: Oseltamivir

Drug: Zanamivir

Drug: Placebo of Oseltamivir

Study type

Interventional

Funder types

Other

Identifiers

NCT00979667

CCT2009-CS-6

Details and patient eligibility

About

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.

Full 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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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