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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Upper Respiratory Tract Infection Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Oseltamivir

Group Type EXPERIMENTAL

Oseltamivir

Intervention Type DRUG

75 mg twice daily for 5 days

Zanamivir

Group Type EXPERIMENTAL

Zanamivir

Intervention Type DRUG

10 mg twice daily for 5 days

Placebo of Oseltamivir

Group Type PLACEBO_COMPARATOR

Placebo of Oseltamivir

Intervention Type DRUG

twice daily for 5 days

Interventions

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Oseltamivir

75 mg twice daily for 5 days

Intervention Type DRUG

Zanamivir

10 mg twice daily for 5 days

Intervention Type DRUG

Placebo of Oseltamivir

twice daily for 5 days

Intervention Type DRUG

Other Intervention Names

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Tamiflu Relenza Tamiflu Placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No