A Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As First Line Treatment For Human Swine Influenza Infection
This study has been terminated.
(Decreased Influenza activity; thus decrease/no eligible patient to recruit)
Sponsor:
Chinese University of Hong Kong
Collaborators:
Food and Health Bureau, The Government of the Hong Kong Special Administrative Region
Hospital Authority
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00979667
First received: September 17, 2009
Last updated: April 8, 2011
Last verified: May 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Upper Respiratory Tract Infection Influenza |
Drug: Oseltamivir Drug: Zanamivir Drug: Placebo of Oseltamivir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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:
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 ]
| Enrollment: | 4 |
| Study Start Date: | October 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Oseltamivir |
Drug: Oseltamivir
75 mg twice daily for 5 days
Other Name: Tamiflu
|
| Experimental: Zanamivir |
Drug: Zanamivir
10 mg twice daily for 5 days
Other Name: Relenza
|
| Placebo Comparator: Placebo of Oseltamivir |
Drug: Placebo of Oseltamivir
twice daily for 5 days
Other Name: Tamiflu Placebo
|
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| 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
Locations
| China, Hong Kong | |
| Shau Kei Wan Jockey Club Clinic | |
| Hong Kong, Hong Kong, China, 852 | |
| Hong Kong | |
| Fanling Family Medicine Centre | |
| Hong Kong, Hong Kong | |
| Sai Ying Pun Jockey Club General Outpatient Clinic | |
| Hong Kong, Hong Kong | |
Sponsors and Collaborators
Chinese University of Hong Kong
Food and Health Bureau, The Government of the Hong Kong Special Administrative Region
Hospital Authority
Investigators
| Principal Investigator: | Augustine T. LAM, MBBS | Prince of Wales Hospital, Shatin, Hong Kong |
More Information
No publications provided
| Responsible Party: | Prof. Benny Chung Ying ZEE and Dr. Augustine Tsan LAM, The Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT00979667 History of Changes |
| Other Study ID Numbers: | CCT2009-CS-6 |
| Study First Received: | September 17, 2009 |
| Last Updated: | April 8, 2011 |
| 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 Respiratory Tract Infections Common Cold Orthomyxoviridae Infections RNA Virus Infections Virus Diseases Respiratory Tract Diseases Infection Picornaviridae Infections |
Zanamivir Oseltamivir Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antiviral Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013