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

Primary Purpose

Upper Respiratory Tract Infection, Influenza

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Oseltamivir

Zanamivir

Placebo of Oseltamivir

About this trial

This is an interventional treatment trial for Upper Respiratory Tract Infection focused on measuring Upper respiratory tract infection, Influenza A, Human Swine Influenza

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Shau Kei Wan Jockey Club Clinic
Fanling Family Medicine Centre
Sai Ying Pun Jockey Club General Outpatient Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Oseltamivir

Zanamivir

Placebo of Oseltamivir

Arm Description

Outcomes

Primary Outcome Measures

Time to symptoms resolution as reported by the patient

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00979667

First Posted

September 17, 2009

Last Updated

April 8, 2011

Sponsor

Chinese University of Hong Kong

Collaborators

Food and Health Bureau, Hong Kong, Hospital Authority

1. Study Identification

Unique Protocol Identification Number

NCT00979667

Brief Title

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

2. Study Status

Record Verification Date

May 2010

Overall Recruitment Status

Terminated

Why Stopped

Decreased Influenza activity; thus decrease/no eligible patient to recruit

Study Start Date

October 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Chinese University of Hong Kong

Collaborators

Food and Health Bureau, Hong Kong, Hospital Authority

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Respiratory Tract Infection, Influenza

Keywords

Upper respiratory tract infection, Influenza A, Human Swine Influenza

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oseltamivir

Arm Type

Experimental

Arm Title

Zanamivir

Arm Type

Experimental

Arm Title

Placebo of Oseltamivir

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Oseltamivir

Other Intervention Name(s)

Tamiflu

Intervention Description

75 mg twice daily for 5 days

Intervention Type

Drug

Intervention Name(s)

Zanamivir

Other Intervention Name(s)

Relenza

Intervention Description

10 mg twice daily for 5 days

Intervention Type

Drug

Intervention Name(s)

Placebo of Oseltamivir

Other Intervention Name(s)

Tamiflu Placebo

Intervention Description

twice daily for 5 days

Primary Outcome Measure Information:

Title

Time to symptoms resolution as reported by the patient

Time Frame

one week

Secondary Outcome Measure Information:

Title

Treatment failure including hospitalization due to disease worsening.

Time Frame

one week

Title

Viral load

Time Frame

one week

Title

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

Time Frame

one week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Augustine T. LAM, MBBS

Organizational Affiliation

Prince of Wales Hospital, Shatin, Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shau Kei Wan Jockey Club Clinic

City

Hong Kong

State/Province

Hong Kong

ZIP/Postal Code

852

Country

China

Facility Name

Fanling Family Medicine Centre

City

Hong Kong

Country

Hong Kong

Facility Name

Sai Ying Pun Jockey Club General Outpatient Clinic

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Learn more about this trial

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

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