Trial registered on ANZCTR


Trial ID
ACTRN12605000550606
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
29/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of new drug treatments including artemisinin combination therapy for uncomplicated malaria in children in Papua New Guinea
Scientific title
Evaluation of new drug treatments including artemisinin combination therapy for uncomplicated malaria in children in Papua New Guinea
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 675 0
Condition category
Condition code
Infection 749 749 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Chloroquine/sulfadoxine/pyrimethamine
Dihydroartemisinin-piperaquine
Artesunate-piperaquine
Chloroquine
These drug regimes will be given by mouth in conventional doses over up to three days as treatment for malaria.
Intervention code [1] 579 0
Treatment: drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 936 0
28-day cure rate as defined by the World Health Organisation
Timepoint [1] 936 0
Secondary outcome [1] 1788 0
Parasite clearance time
Timepoint [1] 1788 0
Secondary outcome [2] 1789 0
Fever clearance time
Timepoint [2] 1789 0

Eligibility
Key inclusion criteria
Children with a history of fever and a blood film positive for either P. falciparum or P. vivax will be eligible provided that: i) they have no features of severe malaria,34 ii) there is no history of prior antimalarial drug use (quinine or artemisinin drugs within 7 days, or a 4-aminoquinoline, pyrimethamine and/or sulphonamide within 28 days), iii) there is no clinical evidence of another infection as a cause of fever, and iv) the childs parents or relatives give informed consent.
Minimum age
4 Years
Maximum age
10 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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)
A sequentially numbered sealed opaque envelope will contain each child's assigned treatment code
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety/efficacy

Recruitment
Anticipated date of first participant enrolment
1/04/2005
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Anticipated date of last data collection
Actual date of last data collection
Target sample size
600
Actual sample size
Recruitment status
Recruiting
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 830 0
Government body
Name [1] 830 0
National Health and Medical Research Council
Address [1] 830 0
Country [1] 830 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 699 0
Government body
Name [1] 699 0
Papua New Guinea Insitute of Medical Research
Address [1] 699 0
Country [1] 699 0
Papua New Guinea

Ethics approval
Ethics application status
Approved

Summary
Brief summary
We aim to assess whether new combination therapies for malaria, based on artemisinin drugs and a chloroquine-like drug piperaquine, will be effective in children with malaria in Papua New Guinea
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35348 0
Address 35348 0
Country 35348 0
Phone 35348 0
Fax 35348 0
Email 35348 0
Contact person for public queries
Name 9768 0
Timothy Davis
Address 9768 0
School of Medicine and Pharmacology
University of Western Australia
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 9768 0
Australia
Phone 9768 0
+61 8 94313229
Fax 9768 0
+61 8 94312977
Email 9768 0
tdavis@cyllene.uwa.edu.au
Contact person for scientific queries
Name 696 0
Timothy Davis
Address 696 0
School of Medicine and Pharmacology
University of Western Australia
Fremantle Hospital
PO Box 480
Fremantle WA 6959
Country 696 0
Australia
Phone 696 0
+61 8 94313229
Fax 696 0
+61 8 94312977
Email 696 0
tdavis@cyllene.uwa.edu.au