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

This study is currently recruiting participants.

Verified by Chinese University of Hong Kong, November 2009

First Received: September 17, 2009 Last Updated: November 4, 2009 History of Changes

Sponsor:	Chinese University of Hong Kong
Collaborators:	Hospital Authority, Hong Kong Food and Health Bureau, Hong Kong
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00979667

Purpose

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.

Condition	Intervention	Phase
Upper Respiratory Tract Infection Influenza	Drug: Oseltamivir Drug: Zanamivir Drug: Placebo of Oseltamivir	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Zanamivir Oseltamivir Tamiflu

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:

Time to symptoms resolution as reported by the patient [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment failure including hospitalization due to disease worsening. [ Time Frame: one week ] [ Designated as safety issue: Yes ]
Viral load [ Time Frame: one week ] [ Designated as safety issue: Yes ]
Severity of disease as measured by the patient diary and quality of life using SF12v2. [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Oseltamivir: Experimental	Drug: Oseltamivir 75 mg twice daily for 5 days
Zanamivir: Experimental	Drug: Zanamivir 10 mg twice daily for 5 days
Placebo of Oseltamivir: Placebo Comparator	Drug: Placebo of Oseltamivir twice daily for 5 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979667

Contacts

Contact: Augustine T. LAM, MBBS	852-2632 1595	lamt@ha.org.hk
Contact: Benny C.Y. ZEE, PhD	852-22528865	bzee@cct.cuhk.edu.hk

Locations

Hong Kong
Fanling Family Medicine Centre	Recruiting
Hong Kong, Hong Kong
Contact: Maria K W LEUNG, MBBS 852-2672 0635 lkw271@ha.org.hk
Sub-Investigator: Maria K W Leung, MBBS
Sai Ying Pun Jockey Club General Outpatient Clinic	Not yet recruiting
Hong Kong, Hong Kong
Contact: Alfred S K Kwong, MBBS 852- 28598216 kwongsk1@ha.org.hk
Sub-Investigator: Alfred S K Kwong, MBBS
Shau Kei Wan Jockey Club Clinic	Not yet recruiting
Hong Kong, Hong Kong
Contact: Michelle M Y Wong, MBBS 852-25569356 wongmy5@ha.org.hk
Sub-Investigator: Michelle M Y Wong, MBBS

Sponsors and Collaborators

Chinese University of Hong Kong

Hospital Authority, Hong Kong

Food and Health Bureau, Hong Kong

Investigators

Principal Investigator:

Augustine T. LAM, MBBS

Prince of Wales Hospital, Hong Kong

More Information

No publications provided

Responsible Party:	The Chinese University of Hong Kong ( Prof. Benny Chung Ying ZEE and Dr. Augustine Tsan LAM )
Study ID Numbers:	CCT2009-CS-6
Study First Received:	September 17, 2009
Last Updated:	November 4, 2009
ClinicalTrials.gov Identifier:	NCT00979667 History of Changes
Health Authority:	Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:

Upper respiratory tract infection
Influenza A
Human Swine Influenza

Additional relevant MeSH terms:

Influenza, Human
Anti-Infective Agents
Communicable Diseases
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Orthomyxoviridae Infections
Infection

Antiviral Agents
Zanamivir
Pharmacologic Actions
Oseltamivir
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses

ClinicalTrials.gov processed this record on February 08, 2010