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Trial registered on ANZCTR


Registration number
ACTRN12610000913077
Ethics application status
Approved
Date submitted
26/10/2010
Date registered
26/10/2010
Date last updated
19/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Artesunate-pyronaridine and artemisinin-naphthoquine combination therapies for Papua New Guinean children with uncomplicated malaria infections
Scientific title
Efficacy of artesunate-pyronaridine and artemisinin-naphthoquine combination therapies compared with standard artemether-lumefantrine in children from Papua New Guinea with uncomplicated malaria who are monitored for recurrent malaria over 42 days post-treatment
Secondary ID [1] 252953 0
Nil
Secondary ID [2] 284286 0
Nil known
Universal Trial Number (UTN)
U1111-1117-5907
Trial acronym
Standard Treatment Trial II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 258484 0
Condition category
Condition code
Infection 258651 258651 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Artesunate-pyronaridine (Pyramax) as artesunate 3 mg/kg and pyronaridine base 10 mg/kg once-daily for three days or artemisinin-naphthoquine (Arco) as artemisinin 20 mg/kg and naphthoquine phosphate 8 mg/kg once-daily for three days. Both drug regimens will be given orally with water. Doses will be calculated from body weight to the nearest whole sachet of granules (Pyramax) or tablets (Arco).
Intervention code [1] 257482 0
Treatment: Drugs
Comparator / control treatment
Artemether-lumefantrine (Novartis Pharma, Basel, Switzerland) as artemether 1.7 mg/kg and lumefantrine 10 mg/kg twice-daily for three days given orally with milk. Doses will be calculated from body weight to the nearest whole tablet.
Control group
Active

Outcomes
Primary outcome [1] 259502 0
Recrudescent Plasmodium falciparum after correction for re-infections using PCR genotyping of polymorphic parasite loci in children with falciparum malaria
Timepoint [1] 259502 0
Within 42 days after initiation of treatment
Primary outcome [2] 259503 0
Appearance of any Plasmodium vivax parasitaemia on blood smear after treatment for vivax malaria.
Timepoint [2] 259503 0
Within 42 days after initiation of treatment
Secondary outcome [1] 266094 0
Reappearance of PCR-uncorrected P. falciparum parasitemia on blood smear after treatment of falciparum malaria
Timepoint [1] 266094 0
Within 42 days after initiation of treatment
Secondary outcome [2] 266095 0
Appearance of any P. vivax parasitemia on blood smear after treatment of falciparum malaria
Timepoint [2] 266095 0
Within 42 days after initiation of treatment
Secondary outcome [3] 266096 0
Appearance of P. falciparum gametocytes on blood smear after treatment of falciparum malaria
Timepoint [3] 266096 0
Within 42 days after initiation of treatment
Secondary outcome [4] 266097 0
Appearance of P. vivax gametocytes on blood smear within 42 daysa fter treatment of vivax malaria
Timepoint [4] 266097 0
Within 42 days after initiation of treatment

Eligibility
Key inclusion criteria
Children with an axillary temperature >37.5 degrees Centigrade or fever during the previous 24 hours with either P. falciparum (>1000 asexual parasites per microlitre whole blood) or P. vivax (>250 per microlitre) on blood smear microscopy
Minimum age
0 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Features of severity, treatment with a study drug or other antimalarial in the previous 28 days, clinical or laboratory evidence of another infection or co-morbidity including malnutrition

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)
Eligible children will be enrolled at participating field sites after parental informed consent has been obtained. The study is open label but randomisation will be by computer generated code contained in a sealed envelope to be opened at the time of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
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
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2010
Actual
2/04/2012
Date of last participant enrolment
Anticipated
30/04/2014
Actual
24/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
637
Accrual to date
Final
Recruitment outside Australia
Country [1] 2995 0
Papua New Guinea
State/province [1] 2995 0
Madang
Country [2] 2996 0
Papua New Guinea
State/province [2] 2996 0
East Sepik
Country [3] 2997 0
Papua New Guinea
State/province [3] 2997 0
East New Britain

Funding & Sponsors
Funding source category [1] 257931 0
Government body
Name [1] 257931 0
National Health and Medical Research Council
Country [1] 257931 0
Australia
Primary sponsor type
University
Name
University of Western Australia
Address
School of Medicine and Pharmacology, Fremantle Hospital, PO Box 480, Fremantle, Western Australia 6959
Country
Australia
Secondary sponsor category [1] 257122 0
Other
Name [1] 257122 0
Papua New Guinea Insitute of Medical Research
Address [1] 257122 0
P O Box 60, Goroka, Eastern Highlands Province 411
Country [1] 257122 0
Papua New Guinea

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259942 0
Medical Research Advisory Committee
Ethics committee address [1] 259942 0
Government of PNG, Department of Health, PO Box 807, Waigani NCD 131
Ethics committee country [1] 259942 0
Papua New Guinea
Date submitted for ethics approval [1] 259942 0
Approval date [1] 259942 0
28/06/2010
Ethics approval number [1] 259942 0
MRAC 10.39
Ethics committee name [2] 259943 0
Human Research Ethics Committee
Ethics committee address [2] 259943 0
University of Western Australia, Crawley 6009
Ethics committee country [2] 259943 0
Australia
Date submitted for ethics approval [2] 259943 0
Approval date [2] 259943 0
07/05/2010
Ethics approval number [2] 259943 0
RA/4/1/4125

Summary
Brief summary
We recently found that the WHO-recommended combination antimalarial therapy artemether-lumefantrine and the candidate regimen dihydroartemisinin-piperaquine were not fully effective for both falciparum and vivax malaria in young Papua New Guinean children, a group at high risk of complications and death. We plan to study two new combinations (artesunate-pyronaridine and artemisinin-naphthoquine) in the hope that at least one will prove superior and be used in treatment programs in PNG and similar countries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31831 0
Prof Timothy Davis
Address 31831 0
School of Medicine and Pharmacology, University of Western Australia, Fremantle Hospital, PO Box 480, Fremantle 6959, Western Australia, Australia
Country 31831 0
Australia
Phone 31831 0
+618 9431 3229
Fax 31831 0
Email 31831 0
tim.davis@uwa.edu.au
Contact person for public queries
Name 15078 0
Prof Timothy Davis
Address 15078 0
University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, PO Box 480, Fremantle, Western Australia 6959
Country 15078 0
Australia
Phone 15078 0
+618 9431 3229
Fax 15078 0
+618 9431 2977
Email 15078 0
tim.davis@uwa.edu.au
Contact person for scientific queries
Name 6006 0
Prof Timothy Davis
Address 6006 0
University of Western Australia, School of Medicine and Pharmacology, Fremantle Hospital, PO Box 480, Fremantle, Western Australia 6959
Country 6006 0
Australia
Phone 6006 0
+618 9431 3229
Fax 6006 0
+618 9431 2977
Email 6006 0
tim.davis@uwa.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseRisk factors for Plasmodium falciparum and Plasmodium vivax gametocyte carriage in Papua New Guinean children with uncomplicated malaria.2016https://dx.doi.org/10.1016/j.actatropica.2016.04.002
EmbaseArtemether-lumefantrine versus artemisinin-naphthoquine in Papua New Guinean children with uncomplicated malaria: A six months post-treatment follow-up study.2015https://dx.doi.org/10.1186/s12936-015-0624-4
EmbaseTemporal changes in Plasmodium falciparum anti-malarial drug sensitivity in vitro and resistance-associated genetic mutations in isolates from Papua New Guinea.2015https://dx.doi.org/10.1186/s12936-015-0560-3
EmbasePyronaridine-artesunate for treating uncomplicated Plasmodium falciparum malaria.2019https://dx.doi.org/10.1002/14651858.CD006404.pub3
EmbaseCost-effectiveness of artemisinin-naphthoquine versus artemether-lumefantrine for the treatment of uncomplicated malaria in Papua New Guinean children.2017https://dx.doi.org/10.1186/s12936-017-2081-8
EmbaseGametocyte clearance kinetics determined by quantitative magnetic fractionation in Melanesian children with uncomplicated malaria treated with artemisinin combination therapy.2015https://dx.doi.org/10.1128/AAC.00136-15
N.B. These documents automatically identified may not have been verified by the study sponsor.