Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000588493
Ethics application status
Approved
Date submitted
8/11/2007
Date registered
16/11/2007
Date last updated
16/11/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Tafenoquine for the Post-Exposure Prophylaxis of Vivax Malaria (Southwest Pacific Type) in Non-Immune Australian Soldiers
Scientific title
Comparison of three different dose regimens of tafenoquine versus primaquine for post-exposure prophylaxis of Plasmodium vivax malaria in the Southwest Pacific.
Universal Trial Number (UTN)
Trial acronym
TQ049
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 2531 0
Condition category
Condition code
Infection 2631 2631 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparison of different tafenoquine regimens for tolerability and efficacy of malaria prevention.
Tafenoquine doses of 400mg once daily, 200mg twice daily and 200mg once daily were given to volunteers orally for 3 days prior to departure from a malarious area.
Intervention code [1] 2264 0
Prevention
Comparator / control treatment
Tafenoquine vs Primaquine control. Primaquine was given orally at a dose of 7.5mg three times daily for 14 days as comparator.
Control group
Active

Outcomes
Primary outcome [1] 3542 0
The primary efficacy parameter was the proportion of subjects with confirmed parasitemia during the 12-month follow-up period
Timepoint [1] 3542 0
Follow up to 12 months
Secondary outcome [1] 5927 0
Time to parasitaemia
Timepoint [1] 5927 0
12 months
Secondary outcome [2] 5928 0
Tolerability
Timepoint [2] 5928 0
Clinical interview at day 3.
Secondary outcome [3] 5929 0
Biochemical safety and pharmacokinetic analysis
Timepoint [3] 5929 0
Blood sampling at day 0 and day 3

Eligibility
Key inclusion criteria
Glucose-6-Phosphate Dehydrogenase (G6PD) normal,
Healthy adults
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnant females or females unwilling to use contraception for 30 days following completion of dosing,
G6PD deficiency,
Taking any other investigational drug within 30 days of last dose,
unwilling or unable to give blood.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Volunteers assigned a unique alpha-numeric identifying code after informed consent obtained.
Allocation was conducted by the Principal Investigator or senior co-investigator on site. As it was an open/unblinded trial there was no concealment of allocation involved. Once allocation was completed the files were held at a central administrative site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
At the beginning of each recruiting day a coin was tossed to determine which drug the initial entry would take then the remainder of volunteers were allocated drug according to a predetermined ratio
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/1999
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2771 0
Commercial sector/Industry
Name [1] 2771 0
GlaxoSmithKline
Country [1] 2771 0
United Kingdom
Funding source category [2] 2772 0
Government body
Name [2] 2772 0
Department of Defence
Country [2] 2772 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Biometrics and Data Sciences,
Harlow
Country
United Kingdom
Secondary sponsor category [1] 2504 0
Government body
Name [1] 2504 0
Department of Defence
Address [1] 2504 0
Canberra ACT 2600
Country [1] 2504 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4693 0
ADMEC - Australian Defence Medical Ethics Committee
Ethics committee address [1] 4693 0
Ethics committee country [1] 4693 0
Australia
Date submitted for ethics approval [1] 4693 0
Approval date [1] 4693 0
05/11/1998
Ethics approval number [1] 4693 0
165/98

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28167 0
Address 28167 0
Country 28167 0
Phone 28167 0
Fax 28167 0
Email 28167 0
Contact person for public queries
Name 11324 0
Nathan Elmes
Address 11324 0
Army Malaria Institute
Gallipoli Barracks
Enoggera 4051
Country 11324 0
Australia
Phone 11324 0
61 7 3332 4801
Fax 11324 0
61 7 3332 4800
Email 11324 0
[email protected]
Contact person for scientific queries
Name 2252 0
Nathan Elmes
Address 2252 0
Army Malaria Institute
Gallipoli Barracks
Enoggera 4051
Country 2252 0
Australia
Phone 2252 0
61 7 3332 4801
Fax 2252 0
61 7 3332 4800
Email 2252 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.