Trial from ANZCTR


Trial ID ACTRN12605000550606
Trial Status: Registered
Date Submitted: 13/09/2005
Date Registered: 29/09/2005
Retrospectively registered

Page 1

Public title Evaluation of new drug treatments including artemisinin combination therapy for uncomplicated malaria in children in Papua New Guinea
Update:
 
Reason:
 
Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Evaluation of new drug treatments including artemisinin combination therapy for uncomplicated malaria in children in Papua New Guinea
Update:
 
Reason:
 
UTN
Update:
 
Reason:
 
Trial acronym
Update:
 

Page 2

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

Page 3

Descriptions 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.
Update:
 
Reason:
 
Intervention Code:
Treatment: drugs 579 0
Update:
 
Reason:
 
Comparator / control treatment
Update:
 
Reason:
 
Control group Active
Update:
 
Reason:
 

Page 4

Primary Outcome: 28-day cure rate as defined by the World Health Organisation 936 0
Update:
 
Reason:
 
Timepoint: 936 0
Update:
 
Reason:
 
Secondary Outcome: Parasite clearance time 1788 0
Update:
 
Reason:
 
Timepoint: 1788 0
Update:
 
Reason:
 
Secondary Outcome: Fever clearance time 1789 0
Update:
 
Reason:
 
Timepoint: 1789 0
Update:
 
Reason:
 

Page 5

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.
Update:
 
Reason:
 
Minimum age 4 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Maximum age 10 Years
Update:
 
Reason:
 
Update:
 
Reason:
 
Gender Both males and females
Update:
 
Reason:
 
Healthy volunteers? No
Update:
 
Reason:
 
Key exclusion criteria No exclusion criteria
Update:
 
Reason:
 

Page 6

Study type Interventional
Update:
 
Reason:
 
Purpose of the study Treatment
Update:
 
Allocation to intervention Randomised controlled trial
Update:
 
Reason:
 
Describe the 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
Update:
 
Reason:
 
Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Computer-generated randomisation
Update:
 
Reason:
 
Masking / blinding Open (masking not used)
Update:
 
Reason:
 
Who is / are masked / blinded (choose all that apply)


Update:
       
Reason:
 
Assignment Parallel
Update:
 
Reason:
 
Other design features
Update:
 
Reason:
 
Type of endpoint(s) Safety/efficacy
Update:
 
Reason:
 
Statistical Methods/Analysis
Update:
 
Reason:
 

Page 7

Phase Phase 3 / Phase 4
Update:
 
Reason:
 
Anticipated date of first participant enrolment 1/04/2005
Update:
 
Reason:
 
Date of first participant enrolment
Update:
 
Reason:
 
Anticipated date last participant recruited/enrolled
Update:
 
Reason:
 
Actual date last participant recruited/enrolled
Update:
 
Reason:
 
Target sample size 600
Update:
 
Reason:
 
Recruitment status Recruiting
Update:
 
Reason:
 

Recruitment in Australia

Recruitment state(s)
Update:
 
Reason:
 

Recruitment outside Australia

Page 8

Funding Source: Government body 830 0
Update:
 
Reason:
 
Name: National Health and Medical Research Council 830 0
Update:
 
Reason:
 
Address: 830 0
Update:
 
Reason:
 
Country: Australia 830 0
Update:
 
Reason:
 
Primary Sponsor University
Update:
 
Reason:
 
Name: University of Western Australia
Update:
 
Reason:
 
Address:
Update:
 
Reason:
 
Country: Australia
Update:
 
Reason:
 
Secondary Sponsor: Government body 699 0
Update:
 
Reason:
 
Name: Papua New Guinea Insitute of Medical Research 699 0
Update:
 
Reason:
 
Address: 699 0
Update:
 
Reason:
 
Country: Papua New Guinea 699 0
Update:
 
Reason:
 

Page 9

Has the study received approval from at least one Ethics Committee? Yes
Update:
 
Reason:
 
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
Update:
 
Reason:
 
Trial website
Update:
 
Trial related presentations / publications
Update:
 
Public Notes
Update:
 

Page 10

Principal Investigator
Title:
Update:
 
Reason:
 
35348 0
Name:
Update:
 
Reason:
 
35348 0
Address:
Update:
 
Reason:
 
35348 0
Country:
Update:
 
35348 0
Reason:
 
Tel:
Update:
 
Reason:
 
35348 0
Fax:
Update:
 
Reason:
 
35348 0
Email:
Update:
 
Reason:
 
35348 0
Contact person for public queries
Title:
Update:
 
Reason:
 
9768 0
Name: Timothy Davis
Update:
 
Reason:
 
9768 0
Address: School of Medicine and Pharmacology University of Western Australia Fremantle Hospital PO Box 480 Fremantle WA 6959
Update:
 
Reason:
 
9768 0
Country: Australia
Update:
 
9768 0
Reason:
 
Tel: +61 8 94313229
Update:
 
Reason:
 
9768 0
Fax: +61 8 94312977
Update:
 
Reason:
 
9768 0
Email: tdavis@cyllene.uwa.edu.au
Update:
 
Reason:
 
9768 0

Contact person for scientific queries
Title:
Update:
 
Reason:
 
696 0
Name: Timothy Davis
Update:
 
Reason:
 
696 0
Address: School of Medicine and Pharmacology University of Western Australia Fremantle Hospital PO Box 480 Fremantle WA 6959
Update:
 
Reason:
 
696 0
Country: Australia
Update:
 
696 0
Reason:
 
Tel: +61 8 94313229
Update:
 
Reason:
 
696 0
Fax: +61 8 94312977
Update:
 
Reason:
 
696 0
Email: tdavis@cyllene.uwa.edu.au
Update:
 
Reason:
 
696 0

Contact person responsible for updating information
Title:
Update:
 
Reason:
 
18840 0
Name:
Update:
 
Reason:
 
18840 0
Address:
Update:
 
Reason:
 
18840 0
Country:
Update:
 
18840 0
Reason:
 
Tel:
Update:
 
Reason:
 
18840 0
Fax:
Update:
 
Reason:
 
18840 0
Email:
Update:
 
Reason:
 
18840 0
   

Addition Cancer fields
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason:
 
Update:
 
Reason: