Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000906257
Ethics application status
Approved
Date submitted
30/07/2009
Date registered
20/10/2009
Date last updated
5/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Unblinded Randomized Study of Influenza A/H1N1 2009 ("Swine flu")Resistance to Oseltamivir and Zanamivir
Scientific title
An Unblinded Randomized Study of Influenza A/H1N1 2009 Resistance to Oseltamivir and Zanamivir
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 252024 0
Condition category
Condition code
Infection 252217 252217 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with clinical symptoms indicative of influenza, who present within 72 h of the onset of fever during confirmed influenza activity in the community and have a positive rapid antigen test for influenza; will be randomized to receive immediate treatment with oseltamivir or zanamivir
according to standard age appropriate dose. Standard Oseltamivir and Zanamivir treatment in influenza is given as twice daily doses for 5 days.
Mode of administration:
Oseltamivir- Capsule, Suspension
Zanamivir-Inhalation
Intervention code [1] 241330 0
Treatment: Drugs
Comparator / control treatment
Oseltamivir vs Zanamivir
Control group
Active

Outcomes
Primary outcome [1] 240918 0
1. Frequency of isolation of resistant virus in subjects aged 5 years or greater
Timepoint [1] 240918 0
01/08/2009-31/12/2009
Secondary outcome [1] 257630 0
1. Reductions in viral load after 5 days of treatment
2. Correlation of viral load with clinical outcome (signs and symptoms) after 5 days of treatment
Timepoint [1] 257630 0
01/08/2009 to 31/12/2010

Eligibility
Key inclusion criteria
1. The age of the patient is at least 5 years to upper limit of 50 years.
2. The patient has a positive rapid antigen test for influenza A or B and symptoms indicative of influenza that have
lasted no more than 72 hours:
a. fever 37.8 degree celsius or subjective fever and
b. at least one respiratory symptom (cough, coryza, sore throat, rhinitis)
Minimum age
5 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Suspicion of invasive bacterial infection requiring immediate admission to hospital.
2. Evidence of a poorly controlled underlying medical condition.
3. Known immunosuppression (malignancy, transplant, drugs).
4. Pregnant or lactating females
5. Known allergy to oseltamivir or zanamivir.
6. Participation in another clinical trial with an investigational drug.
7. Participant with insufficient English language skills.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be recruited based on the study inclusion and exclusion criterias. Treatment with either oseltamivir or zanamivir will be allocated randomly. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using the random number tables.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Un-blinded randomized control trail
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243895 0
Government body
Name [1] 243895 0
NHMRC
Country [1] 243895 0
Australia
Primary sponsor type
University
Name
Prof Robert Booy
Address
National Centre for Immunization Research and Surveillance (NCIRS)
The Childrens Hospital at Westmead
Locked Bag 4001
Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 251238 0
None
Name [1] 251238 0
Address [1] 251238 0
Country [1] 251238 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239549 0
Sydney West Area Health Service Human Research Ethics Committee(HREC) - Westmead Campus
Ethics committee address [1] 239549 0
Research Office
Westmead Hospital
Rm 2020, Clinical Sciences, 2nd Floor
WESTMEAD NSW 2145
Ethics committee country [1] 239549 0
Australia
Date submitted for ethics approval [1] 239549 0
30/07/2009
Approval date [1] 239549 0
Ethics approval number [1] 239549 0
EC00152

Summary
Brief summary
The main purpose of this study is to assess the frequency of emergence of oseltamivir and zanamivir resistant
influenza viruses, and their virological characteristics, in patients treated with oseltamivir and zanamivir for influenza
caused by A/H1N1 2009 (‘swine flu’) and other human influenza viruses during periods of high transmission. Limited
clinical information will also be collected.
Patients with clinical symptoms indicative of influenza, who present within 72 h of the onset of fever during confirmed
influenza activity in the community, will be randomized to receive immediate treatment with oseltamivir or zanamivir
according to standard age appropriate dose. Patients will have baseline virus samples taken for typing and oseltamivir
and zanamivir sensitivity and also on completion of treatment (After 5 days of treatment). Limited clinical information
will also be collected.
Trial website
Not applicable
Trial related presentations / publications
Not yet published
Public notes

Contacts
Principal investigator
Name 29982 0
Address 29982 0
Country 29982 0
Phone 29982 0
Fax 29982 0
Email 29982 0
Contact person for public queries
Name 13229 0
Dr Gulam Khandaker
Address 13229 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
Research Building
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Locked Bag 4001
WESTMEAD NSW 2145
Country 13229 0
Australia
Phone 13229 0
+61 2 9845 1427
Fax 13229 0
+61 2 9845 1418
Email 13229 0
gulamk@chw.edu.au
Contact person for scientific queries
Name 4157 0
Prof Robert Booy
Address 4157 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
Research Building
The Children's Hospital at Westmead
Cnr Hawkesbury Rd and Hainsworth St
Locked Bag 4001
WESTMEAD NSW 2145
Country 4157 0
Australia
Phone 4157 0
+61 2 9845 1415
Fax 4157 0
+61 2 9845 1418
Email 4157 0
robertb2@chw.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.