Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000004066
Ethics application status
Approved
Date submitted
24/12/2009
Date registered
5/01/2010
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 under standard and double dose oseltamivir treatment in participants with influenza
Scientific title
An unblinded randomized study of influenza A/H1N1 2009 resistance under standard and double dose oseltamivir treatment in participants with influenza
Secondary ID [1] 1228 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 256444 0
Condition category
Condition code
Infection 256616 256616 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The main purpose of this study is to assess the frequency of emergence of oseltamivir resistant viruses, and their virological characteristics, in patients treated with standard and double dose oseltamivir (oral capsules or suspension) 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.

This is an unblinded randomized study. Patients with clinical symptoms indicative of influenza, who present within 48 hours of the onset of fever during confirmed influenza activity in the community, will be randomized to receive immediate treatment with oseltamivir at a standard age-appropriate dose or a double dose, twice daily for 5 days. Patients will have baseline virus samples taken for typing and oseltamivir sensitivity and also on day 5 of treatment.
Intervention code [1] 255738 0
Treatment: Drugs
Comparator / control treatment
standard versus double dose of oseltamivir
Control group
Active

Outcomes
Primary outcome [1] 257509 0
The objectives of this study are to investigate the effectiveness of double dose Oseltamivir treatment initiated within 48 hours of the onset of influenza symptoms compared with standard dose Oseltamivir on:
Primary
1. frequency of isolation of resistant virus in subject aged 5 years or greater.

Virological test including culture/polymerase chain reaction (PCR) will be done to check viral resistance.
Timepoint [1] 257509 0
Every patient will be treated for 5 days with oseltamivir. Nasal swab for virological test will be collected before commencing the treatment (Day 1) and after 5 days (Day 5) of treatment.
Secondary outcome [1] 262728 0
1. reductions in viral load
Timepoint [1] 262728 0
Nasal swab for virological test (culture/PCR) will be collected before commencing the treatment (Day 1) and after 5 days (Day 5) of treatment.
Secondary outcome [2] 262755 0
2. Presence or absence of clinical signs and symptoms in patients shedding resistant virus at day 5.
Timepoint [2] 262755 0
Clinical information collected before commencing the treatment (Day 1) and after 5 days (Day 5) of treatment.
Secondary outcome [3] 262756 0
3. Do those who begin treatment after 24 hours and up to 48 hours derive benefit from the treatment? Stratified analysis by duration (<24hours, 24 to 48hours) of symptoms before commencement of treatment.
Timepoint [3] 262756 0
Clinical information collected before commencing the treatment (Day 1) and after 5 days (Day 5) of treatment.

Eligibility
Key inclusion criteria
Participants must meet all of the following inclusion criteria to participate in this study:
1. The age of the patient is at least 5 years.
2. The patient has a positive rapid antigen test for influenza A and symptoms indicative of influenza that have lasted
no more than 48 hours:
- fever >= 37.8 celsius and
- at least one respiratory symptom (cough, coryza, sore throat, rhinitis)
Minimum age
5 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If one or more of the following criteria are met, the participant will be ineligible to take part in this study:
1. Clinical suspicion of infection with a respiratory virus other than influenza.
2. Suspicion of invasive bacterial infection requiring immediate admission to hospital.
3. Evidence of a poorly controlled underlying medical condition.
4. Known immunosuppression (malignancy, transplant, drugs)
5. Pregnant or lactating females
6. Known allergy to oseltamivir.
7. Participation in another clinical trial with an investigational drug.
8. Participant with insufficient English language skills.
9. A person about whom the investigator thinks that the person is unlikely to comply with the study requirements.

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)
Those who will meet the inclusion criteria would be randomly allocated either in standard or double dose oseltamivir group.
Allocation concealment will be dome using sealed envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random sequence would be generated by computer by block randomisation method, by block of six.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256212 0
Commercial sector/Industry
Name [1] 256212 0
Roche Products Pty Ltd
Country [1] 256212 0
Australia
Primary sponsor type
University
Name
National Centre for Immunisation Research and Surveillance (NCIRS)
Address
NCIRS
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW-2145
Country
Australia
Secondary sponsor category [1] 251552 0
None
Name [1] 251552 0
Address [1] 251552 0
Country [1] 251552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258313 0
Royal Alexandra Hospital for Children Ethics Committee (EC00130)
Ethics committee address [1] 258313 0
The Childrens Hospital at Westmead
Locked Bag 4001
Westmead
NSW-2145
Ethics committee country [1] 258313 0
Australia
Date submitted for ethics approval [1] 258313 0
19/05/2009
Approval date [1] 258313 0
03/08/2009
Ethics approval number [1] 258313 0

Summary
Brief summary
This study will assess the frequency of emergence of oseltamivir resistant viruses, and their virological characteristics, in patients treated with standard and double dose oseltamivir for influenza caused by A/H1N1 2009 (‘swine flu’) and other human influenza viruses.

Patients with clinical symptoms indicative of influenza, who present within 48 hours of the onset of fever during confirmed influenza activity in the community, will be randomised to receive immediate treatment with oseltamivir at a standard age appropriate dose or a double dose, twice daily for 5 days. Patients will have baseline virus samples taken for typing and oseltamivir sensitivity and also on day 5 of treatment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30643 0
Address 30643 0
Country 30643 0
Phone 30643 0
Fax 30643 0
Email 30643 0
Contact person for public queries
Name 13890 0
Prof Robert Booy
Address 13890 0
NCIRS
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW-2145
Country 13890 0
Australia
Phone 13890 0
+61 02 9845 1415
Fax 13890 0
+61 02 9845 1418
Email 13890 0
[email protected]
Contact person for scientific queries
Name 4818 0
Prof Robert Booy
Address 4818 0
NCIRS
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW-2145
Country 4818 0
Australia
Phone 4818 0
+61 02 9845 1415
Fax 4818 0
+61 02 9845 1418
Email 4818 0
[email protected]

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.