Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
An unblinded randomized study of influenza A/H1N1 2009 resistance under standard and double dose oseltamivir treatment in participants with influenza
Query!
Secondary ID [1]
1228
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Influenza
256444
0
Query!
Condition category
Condition code
Infection
256616
256616
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
255738
0
Treatment: Drugs
Query!
Comparator / control treatment
standard versus double dose of oseltamivir
Query!
Control group
Active
Query!
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.
Query!
Assessment method [1]
257509
0
Query!
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.
Query!
Secondary outcome [1]
262728
0
1. reductions in viral load
Query!
Assessment method [1]
262728
0
Query!
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.
Query!
Secondary outcome [2]
262755
0
2. Presence or absence of clinical signs and symptoms in patients shedding resistant virus at day 5.
Query!
Assessment method [2]
262755
0
Query!
Timepoint [2]
262755
0
Clinical information collected before commencing the treatment (Day 1) and after 5 days (Day 5) of treatment.
Query!
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.
Query!
Assessment method [3]
262756
0
Query!
Timepoint [3]
262756
0
Clinical information collected before commencing the treatment (Day 1) and after 5 days (Day 5) of treatment.
Query!
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)
Query!
Minimum age
5
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
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.
Query!
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.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 4
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
1/12/2009
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
125
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Funding & Sponsors
Funding source category [1]
256212
0
Commercial sector/Industry
Query!
Name [1]
256212
0
Roche Products Pty Ltd
Query!
Address [1]
256212
0
Roche Products Pty Ltd
4-10 Inman Road
Dee Why NSW-2099
Query!
Country [1]
256212
0
Australia
Query!
Primary sponsor type
University
Query!
Name
National Centre for Immunisation Research and Surveillance (NCIRS)
Query!
Address
NCIRS
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW-2145
Query!
Country
Australia
Query!
Secondary sponsor category [1]
251552
0
None
Query!
Name [1]
251552
0
Query!
Address [1]
251552
0
Query!
Country [1]
251552
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
258313
0
Royal Alexandra Hospital for Children Ethics Committee (EC00130)
Query!
Ethics committee address [1]
258313
0
The Childrens Hospital at Westmead Locked Bag 4001 Westmead NSW-2145
Query!
Ethics committee country [1]
258313
0
Australia
Query!
Date submitted for ethics approval [1]
258313
0
19/05/2009
Query!
Approval date [1]
258313
0
03/08/2009
Query!
Ethics approval number [1]
258313
0
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
30643
0
Query!
Address
30643
0
Query!
Country
30643
0
Query!
Phone
30643
0
Query!
Fax
30643
0
Query!
Email
30643
0
Query!
Contact person for public queries
Name
13890
0
Prof Robert Booy
Query!
Address
13890
0
NCIRS
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW-2145
Query!
Country
13890
0
Australia
Query!
Phone
13890
0
+61 02 9845 1415
Query!
Fax
13890
0
+61 02 9845 1418
Query!
Email
13890
0
[email protected]
Query!
Contact person for scientific queries
Name
4818
0
Prof Robert Booy
Query!
Address
4818
0
NCIRS
The Children's Hospital at Westmead
Locked Bag 4001
Westmead
NSW-2145
Query!
Country
4818
0
Australia
Query!
Phone
4818
0
+61 02 9845 1415
Query!
Fax
4818
0
+61 02 9845 1418
Query!
Email
4818
0
[email protected]
Query!
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.
Download to PDF