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Trial registered on ANZCTR


Registration number
ACTRN12618001621202
Ethics application status
Approved
Date submitted
7/08/2018
Date registered
2/10/2018
Date last updated
2/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapeutic efficacy of pyronaridine-artesunate for Plasmodium vivax in Myanmar
Scientific title
Efficacy and safety of pyronaridine-artesunate for Plasmodium vivax in Kawthaung –Mawhtaung, Tanintharyi Region and KyaInSeikgyi-Myawaddy, Kayin State in Myanmar.
Secondary ID [1] 295757 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 309156 0
Condition category
Condition code
Infection 308038 308038 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treating malaria patients with pyronaridine-artesunate combination
Pyronaridine-artesunate, a fixed dose of tablet formula with 180 mg pyronaridine tetraphosphate and 60 mg artesunate, and granules for oral suspension formula for children with 60 mg pyronaridine tetraphosphate and 20 mg artesunate, will be administered as a weight per dose regimen. The correct drug dosage will be determined from the dosing chart as follow;For children
Sachets of Granules for oral suspension containing 60mg/20mg of Pyronaridine tetraphosphate/Artesunate. For those with body weight 5 to less than 8 kg, 1 sachet each on day1, 2, and 3, for those with body weight 8 kg to less than 15 kg, 2 sachet each on day 1, 2, and 3, for those with 15 kg to less than 20 kg, 3 sachet each on day 1, 2, and 3.

For adult
Oral tablets containing 180mg/60mg of Pyronaridine tetraphosphate/Artesunate were used. For those with body weight 20 to less than 24 kg, one tablet each on day 1, 2, and 3, for those with 24 kg to less than 45 kg, 2 tablets each on day 1, 2, and 3, for those with 45 kg to less than 65 kg, 3 tablets each on day 1, 2, and 3, and for those with 65 kg and above body weight, 4 tablets each on day 1, 2, and 3 were given.

Every first dose of the treatment is given by Team leader of field team, usually Medical Officer, then following dosed are by malaria volunteers. All empty blisters are recollected to monitor the adherence.
Intervention code [1] 312088 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307028 0
Therapeutic efficacy of Pyronaridine-artesunate in Plasmodium vivax in terms of either treatment success or failure after clinicaly and parasitologically monitoring of patients for 42 days. Clinical assessment of jaundice, measurement of body temperature, and hemoglobin, capillary blood collection for screening of malaria parasite by rapid test and microscopy.
Treatment outcomes will be categorized according to WHO definition as follow;
Early treatment failure
• danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia;
• parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature;
• parasitaemia on day 3 with axillary temperature equal to or equal to 37.5 ºC;
• parasitaemia on day 3 equal to or more than 25% of count on day 0.
Late treatment failure
Late clinical failure
• danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 42 in patients who did not previously meet any of the criteria of early treatment failure;
• presence of parasitaemia on any day between day 4 and day 28 with axillary temperature equal to or more than 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure
Late parasitological failure
• presence of parasitaemia on any day between day 7 and day 42 with axillary temperature less than 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure
Adequate clinical and parasitological response
• absence of parasitaemia on day 42, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure
Timepoint [1] 307028 0
At the end of 42 days follow up (follow up dates are day 3, day 7. day 14. day 21, day 28, day 35, day 42)
Secondary outcome [1] 350426 0
Safety of pyronaridine-artesunate in Plasmodium vivax malaria
Safety will be assessed by recording the nature and incidence of adverse events and serious adverse events. Adverse events will be assessed by direct questioning. An adverse event is defined as any unfavourable, unintended sign, symptom, syndrome or disease that develops or worsens with the use of a medicinal product, regardless of whether it is related to the medicinal product. All adverse events must be recorded on the case report form.
A serious adverse event is defined as any untoward medical occurrence that at any dose:
• results in death, is life threatening;
• requires hospitalization or prolongation of hospitalization;
• results in a persistent or significant disability or incapacity; or
• is a congenital anomaly or birth defect.
‘Life-threatening’ means that the person was at immediate risk for death; it does not refer to an adverse event that might have caused death if it were more severe. ‘Persistent or significant disability or incapacity’ means that a person’s ability to carry out normal life functions is substantially disrupted.
All serious adverse events occurring during the study must be recorded and reported by the principal investigator to the sponsor or its designee, and to WHO (ringwaldp@who.int) regardless of whether the principal investigator considers the events to be related to the investigated medicine.
Timepoint [1] 350426 0
During the follow up period of 28 days, frequency and nature of adverse events will be monitored.

Eligibility
Key inclusion criteria
• patients aged 6 year and above
• mono-infection with P. vivax detected by microscopy (parasitaemia > 250/µl asexual forms);
• presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 h
• ability to swallow oral medication;
• ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
• informed consent from the patient or from a parent or guardian in the case of children aged less than age of majority;
• informed assent from any minor participant aged from 12 to age of majority years; and
• consent for pregnancy testing from female of child-bearing age(defined as age > 17 years and sexually active).
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• presence signs of severe falciparum malaria according to the definitions of WHO
• mixed or mono-infection with another Plasmodium species detected by microscopy;
• female aged from 12 and 17 years;
• Body weight under 20 kg;
• presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
• regular medication, which may interfere with antimalarial pharmacokinetics;
• history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
• a positive pregnancy test or breastfeeding; and
• unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age(defined as age > 12 years and sexually active).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/01/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
140
Accrual to date
Final
Recruitment outside Australia
Country [1] 20733 0
Myanmar
State/province [1] 20733 0
Tanintharyi Region & Kayin State

Funding & Sponsors
Funding source category [1] 300347 0
Other
Name [1] 300347 0
WHO/GMS (World Health Organization/Greater Mekong Subregion)
Country [1] 300347 0
Malaysia
Primary sponsor type
Government body
Name
Ministry of Health and Sports
Address
Office number (4), Zeyahtani Road, Nay Pyi Ta 15011 Ministry of Health and Sports Office,
Country
Myanmar
Secondary sponsor category [1] 299790 0
None
Name [1] 299790 0
Address [1] 299790 0
Country [1] 299790 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301163 0
Ethics Review Committee, Department of Medical Research, Ministry of Health & Sports
Ethics committee address [1] 301163 0
Ethics committee country [1] 301163 0
Myanmar
Date submitted for ethics approval [1] 301163 0
Approval date [1] 301163 0
17/07/2018
Ethics approval number [1] 301163 0
Ethics/DMR/2015/119AEAE/2018

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

Contacts
Principal investigator
Name 86058 0
Dr KAY THWE HAN
Address 86058 0
Department of Medical Research
No.5, Ziwaka Road, Dagon Township, Yangon 11191
Country 86058 0
Myanmar
Phone 86058 0
95 9 5169228
Fax 86058 0
95 1 251514
Email 86058 0
drkaythwehan@yahoo.com
Contact person for public queries
Name 86059 0
KAY THWE HAN
Address 86059 0
Department of Medical Research
No.5, Ziwaka Road, Dagon Township, Yangon 11191
Country 86059 0
Myanmar
Phone 86059 0
95 9 5169228
Fax 86059 0
95 1 251514
Email 86059 0
drkaythwehan@yahoo.com
Contact person for scientific queries
Name 86060 0
Pascal Ringwald
Address 86060 0

Global Malaria Programme, WHO Headquaters, Geneva
20 Avenue Appia
1211 Geneva 27
Switzerland
Country 86060 0
Swaziland
Phone 86060 0
+ 41 22 7913469
Fax 86060 0
Email 86060 0
ringwaldp@who.int

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
Dimensions AIEfficacy and Safety of Pyronaridine–Artesunate for the Treatment of Uncomplicated Plasmodium falciparum and Plasmodium vivax Malaria in Myanmar2020https://doi.org/10.4269/ajtmh.20-0185
N.B. These documents automatically identified may not have been verified by the study sponsor.