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

Information source: Chinese University of Hong Kong
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Upper Respiratory Tract Infection; Influenza

Intervention: Oseltamivir (Drug); Zanamivir (Drug); Placebo of Oseltamivir (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Chinese University of Hong Kong

Official(s) and/or principal investigator(s):
Augustine T. LAM, MBBS, Principal Investigator, Affiliation: Prince of Wales Hospital, Shatin, Hong Kong

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Time to symptoms resolution as reported by the patient

Secondary outcome:

Treatment failure including hospitalization due to disease worsening.

Viral load

Severity of disease as measured by the patient diary and quality of life using SF12v2.

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Fanling Family Medicine Centre, Hong Kong, Hong Kong

Sai Ying Pun Jockey Club General Outpatient Clinic, Hong Kong, Hong Kong

Shau Kei Wan Jockey Club Clinic, Hong Kong, Hong Kong 852, China

Additional Information

Starting date: October 2009
Last updated: April 8, 2011

Page last updated: August 23, 2015

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