Clinical trial NCT00979667: A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Upper Respiratory Tract Infection
Influenza
Keywords: Upper respiratory tract infection
Influenza A
Human Swine Influenza
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Food and Health Bureau, Hong Kong
name: Hospital Authority
First posted: 2009-09-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Time to symptoms resolution as reported by the patient
timeFrame: one week
Secondary outcomes:
measure: Treatment failure including hospitalization due to disease worsening.
timeFrame: one week
measure: Viral load
timeFrame: one week
measure: Severity of disease as measured by the patient diary and quality of life using SF12v2.
timeFrame: one week
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Shau Kei Wan Jockey Club Clinic
state: Hong Kong
city: Hong Kong
country: Hong Kong
facility: Fanling Family Medicine Centre
city: Hong Kong
country: Hong Kong
facility: Sai Ying Pun Jockey Club General Outpatient Clinic
Study officials:
affiliation: Prince of Wales Hospital, Shatin, Hong Kong
name: Augustine T. LAM, MBBS
role: PRINCIPAL_INVESTIGATOR
References: