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Trial registered on ANZCTR


Registration number
ACTRN12618001620213
Ethics application status
Approved
Date submitted
6/08/2018
Date registered
2/10/2018
Date last updated
2/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Therapeutic efficacy studies of pyronaridine-artesunate combination for the treatment of uncomplicated Plasmodium falciparum malaria in Myanmar
Scientific title
Efficacy and safety of pyronaridine-artesunate combination for the treatment of uncomplicated Plasmodium falciparum malaria in Kawthaung –Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy , Kayin State in Myanmar
Secondary ID [1] 295753 0
WHO Reference 2018/782467-0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 309153 0
Fever 309154 0
Condition category
Condition code
Infection 308035 308035 0 0
Studies of infection and infectious agents
Public Health 308036 308036 0 0
Epidemiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treat the patients with
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
Body weight (kg) Number of Sachets
Day 0 Day 1 Day 2
5-<8kg 1 1 1
8-<15kg 2 2 2
15-<20kg 3 3 3

For adult
Tablets containing 180mg/60mg of Pyronaridine tetraphosphate/Artesunate
Body weight (kg) Number of tablets
Day 0 Day 1 Day 2
20-<24kg 1 1 1
24-<45kg 2 2 2
45-<65kg 3 3 3
= or >65kg 4 4 4
To monitor the adherence, first dose of ACT is given as directly observed treatment (DOT), then following doses are by malaria health volunteers and empty blisters are recollected and checked.
Intervention code [1] 312082 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307025 0
Therapeutic efficacy of Pyronaridine-artesunate in Plasmodium falciparum malaria will be either treatment success or failure after parasitological and clinical monitoring during the follow up period of 42 days. Clinical assessment of jaundice, taking body temperature, measurement of hemoglobin, taking capillary blood samples for screening of malaria by rapid test and microscopy.
Treatment outcome will be categorized according to WHO 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 more than 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 42 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] 307025 0
At the end of the follow up period of 42 days (follow up dates are day3, 7, 14, 21, 28, 35, and 42)
Secondary outcome [1] 350421 0
Safety of pyronaridine-artesunate in Plasmodium falciparum 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, Shin Poong Pharmaceutical (safety@artemidapharma.com), and to WHO (ringwaldp@who.int) regardless of whether the principal investigator considers the events to be related to the investigated medicine.
Timepoint [1] 350421 0
During the follow up period of 42 days, the frequency and nature of adverse events will be monitored.

Eligibility
Key inclusion criteria
• patients aged 6 year and above
• mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/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 as follow;
• 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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
18/03/2018
Date of last participant enrolment
Anticipated
15/11/2018
Actual
Date of last data collection
Anticipated
31/12/2018
Actual
Sample size
Target
140
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 20732 0
Myanmar
State/province [1] 20732 0
Tanintharyi Region & Kayin State

Funding & Sponsors
Funding source category [1] 300344 0
Other
Name [1] 300344 0
WHO/GMS (World Health Organization/Greater Mekong Subregion)
Country [1] 300344 0
Malaysia
Primary sponsor type
Government body
Name
Ministry of Health and Sports
Address
Office number 4,, Zeya Htani Road, Nay Pyi Taw, 15011
Country
Myanmar
Secondary sponsor category [1] 299969 0
None
Name [1] 299969 0
Address [1] 299969 0
Country [1] 299969 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301159 0
Ethics Review Committee, Department of Medical Research, Ministry of Health & Sports
Ethics committee address [1] 301159 0
Ethics committee country [1] 301159 0
Myanmar
Date submitted for ethics approval [1] 301159 0
Approval date [1] 301159 0
31/07/2017
Ethics approval number [1] 301159 0
Ethics/DMR/2015/119AEA/2017

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

Contacts
Principal investigator
Name 86046 0
Dr KAY THWE HAN
Address 86046 0
Department of Medical Research
No. 5, Ziwaka Road, Dagon Township, Yangon 11191
Country 86046 0
Myanmar
Phone 86046 0
95 9 5169228
Fax 86046 0
95 1 251514
Email 86046 0
drkaythwehan@yahoo.com
Contact person for public queries
Name 86047 0
KAY THWE HAN
Address 86047 0
Department of Medical Research
No. 5, Ziwaka Road, Dagon Township, Yangon 11191
Country 86047 0
Myanmar
Phone 86047 0
95 9 5169228
Fax 86047 0
95 1 251514
Email 86047 0
drkaythwehan@yahoo.com
Contact person for scientific queries
Name 86048 0
Pascal Ringwald
Address 86048 0
Drug Efficacy and Response
Global Malaria Programme
WHO Headquarters
20 Avenue Appia
1211 Geneva 27
Switzerland
Country 86048 0
Switzerland
Phone 86048 0
+ 41 22 7913469
Fax 86048 0
Email 86048 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
EmbaseEfficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Pplasmodium falciparum and plasmodium vivax malaria in Myanmar.2020https://dx.doi.org/10.4269/ajtmh.20-0185
N.B. These documents automatically identified may not have been verified by the study sponsor.