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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
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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
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Secondary ID [1]
295753
0
WHO Reference 2018/782467-0
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
malaria
309153
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Fever
309154
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Condition category
Condition code
Infection
308035
308035
0
0
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Studies of infection and infectious agents
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Public Health
308036
308036
0
0
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Epidemiology
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
312082
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Treatment: Drugs
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
307025
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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
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Assessment method [1]
307025
0
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Timepoint [1]
307025
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At the end of the follow up period of 42 days (follow up dates are day3, 7, 14, 21, 28, 35, and 42)
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Secondary outcome [1]
350421
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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 (
[email protected]
), and to WHO (
[email protected]
) regardless of whether the principal investigator considers the events to be related to the investigated medicine.
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Assessment method [1]
350421
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Timepoint [1]
350421
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During the follow up period of 42 days, the frequency and nature of adverse events will be monitored.
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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).
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Minimum age
6
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
18/03/2018
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Date of last participant enrolment
Anticipated
15/11/2018
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Actual
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Date of last data collection
Anticipated
31/12/2018
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Actual
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Sample size
Target
140
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Accrual to date
40
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Final
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Recruitment outside Australia
Country [1]
20732
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Myanmar
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State/province [1]
20732
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Tanintharyi Region & Kayin State
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Funding & Sponsors
Funding source category [1]
300344
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Other
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Name [1]
300344
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WHO/GMS (World Health Organization/Greater Mekong Subregion)
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Address [1]
300344
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Block 3510, Jalan Teknokrat 6, 630000 Cyberjaya
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Country [1]
300344
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Malaysia
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Primary sponsor type
Government body
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Name
Ministry of Health and Sports
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Address
Office number 4,, Zeya Htani Road, Nay Pyi Taw, 15011
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Country
Myanmar
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Secondary sponsor category [1]
299969
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None
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Name [1]
299969
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Address [1]
299969
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Country [1]
299969
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301159
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Ethics Review Committee, Department of Medical Research, Ministry of Health & Sports
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Ethics committee address [1]
301159
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No. 5, Ziwaka Road, Dagon Township, Yangon 11191, Myanmar
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Ethics committee country [1]
301159
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Myanmar
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Date submitted for ethics approval [1]
301159
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Approval date [1]
301159
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31/07/2017
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Ethics approval number [1]
301159
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Ethics/DMR/2015/119AEA/2017
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Summary
Brief summary
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
Purpose is to assess the efficacy of pyronaridine- artesunate (an alternative artemisinin-based combination treatment) for the treatment of uncomplicated Plasmodium falciparum malaria to support updating of the national policy. The study will be conducted at Kawthaung –Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy, Kayin State,
during May to December 2017 in both study sites. It is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated malaria. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with pyronaridine-atesunate for uncomplicated P. falciparum malaria and monitored for 42 day. Total 140 (70 patients at each study site) will be included. Clinical and parasitological parameters will be monitored over a 42 day follow-up period for Pf to evaluate drug efficacy of pyronaridine-artesunate combination.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
86046
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Dr KAY THWE HAN
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Address
86046
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Department of Medical Research
No. 5, Ziwaka Road, Dagon Township, Yangon 11191
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Country
86046
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Myanmar
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Phone
86046
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95 9 5169228
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Fax
86046
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95 1 251514
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Email
86046
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[email protected]
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Contact person for public queries
Name
86047
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Dr KAY THWE HAN
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Address
86047
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Department of Medical Research
No. 5, Ziwaka Road, Dagon Township, Yangon 11191
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Country
86047
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Myanmar
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Phone
86047
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95 9 5169228
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Fax
86047
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95 1 251514
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Email
86047
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[email protected]
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Contact person for scientific queries
Name
86048
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Dr Pascal Ringwald
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Address
86048
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Drug Efficacy and Response
Global Malaria Programme
WHO Headquarters
20 Avenue Appia
1211 Geneva 27
Switzerland
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Country
86048
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Switzerland
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Phone
86048
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+ 41 22 7913469
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Fax
86048
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Email
86048
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Efficacy and safety of pyronaridine-artesunate for the treatment of uncomplicated Pplasmodium falciparum and plasmodium vivax malaria in Myanmar.
2020
https://dx.doi.org/10.4269/ajtmh.20-0185
N.B. These documents automatically identified may not have been verified by the study sponsor.
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