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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00979667
• Other study ID #: CCT2009-CS-6
• Status: Terminated
• Phase: Phase 3
• First received: September 17, 2009
• Last updated: April 8, 2011
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: May 2010
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza
• Influenza, Human
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Drug:
• Oseltamivir
75 mg twice daily for 5 days
• Zanamivir
10 mg twice daily for 5 days
• Placebo of Oseltamivir
twice daily for 5 days

Locations

Country	Name	City	State
China	Shau Kei Wan Jockey Club Clinic	Hong Kong	Hong Kong
Hong Kong	Fanling Family Medicine Centre	Hong Kong
Hong Kong	Sai Ying Pun Jockey Club General Outpatient Clinic	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Food and Health Bureau, Hong Kong, Hospital Authority

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to symptoms resolution as reported by the patient		one week	No
Secondary	Treatment failure including hospitalization due to disease worsening.		one week	Yes
Secondary	Viral load		one week	Yes
Secondary	Severity of disease as measured by the patient diary and quality of life using SF12v2.		one week	Yes