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Trial registered on ANZCTR
Registration number
ACTRN12618001623280
Ethics application status
Approved
Date submitted
7/08/2018
Date registered
3/10/2018
Date last updated
3/10/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Therapeutic efficacy studies (TES) of antimalarials in Tanintharyi Region and Kayin State, Myanmar
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Scientific title
Efficacy and safety of chloroquine for Plasmodium vivax in Kawthaung –Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy, Kayin State in Myanmar.
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Secondary ID [1]
295758
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None
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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
309157
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Fever
309158
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Headache
309373
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Anaemia
309375
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Condition category
Condition code
Infection
308239
308239
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treating malaria patients with chloroquine in standard dose and course described in Malaria Manual for private the general practice.
Chloroquine tablets containing 250 mg chloroquine phosphate over three days will be given orally (10mg/kg/day on the first two days and 5 mg/kg on the 3rd day) (total dose 25mg base/kg) as the treatment of choice for P. vivax infection and for radical curative treatment with primaquine oral tablet (0.25mg base/kg/day for 14 days). If there is mild G6PD deficiency then 0.75mg/kg is given once weekly for 8 weeks.
To monitor adherence, fist dose of treatment was given directly observed by Field team leader, usually medical officer, then following doses by malaria volunteers. Empty blistered cards were recollected.
The trial objective is to monitor the efficacy of CQ, but primaquine is given to kill liver stage hypnozoites to prevent relapse and also to block transmission of vivax malaria to other.
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Intervention code [1]
312089
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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]
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Therapeutic efficacy of chloroquine in Plasmodium vivax in terms of either treatment success or failure after following the patients parasitologically or clinically for 28 days.
Monitoring procedures included checking presence of jaundice, measurement of hemoglobin, taking body temperature, collecting capillary blood samples for malaria parasite by rapid test and microscopy.
Treatment outcomes are 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 greater than 37.5 ºC;
• parasitaemia on day 3 greater than or equal to 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 28 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 less 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 28 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 28, 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]
307029
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Timepoint [1]
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At the end of follow up 28 days (follow up visits on day 3, day 7, day 14, day 21, day 28),
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Secondary outcome [1]
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Safety of chloroquine in Plasmodium vivax.
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 (
[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]
350427
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Timepoint [1]
350427
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Through out the follow up 28 days, occurrence of adverse events of severe adverse events will be monitored and the frequency and nature of adverse events will be reported.
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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).
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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
• 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Stopped early
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Data analysis
Data collected is being analysed
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Budgeting period is over.
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Date of first participant enrolment
Anticipated
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Actual
15/08/2017
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Date of last participant enrolment
Anticipated
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Actual
1/11/2017
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Date of last data collection
Anticipated
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Actual
25/12/2017
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Sample size
Target
140
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Accrual to date
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Final
100
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Recruitment outside Australia
Country [1]
20735
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Myanmar
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State/province [1]
20735
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Tanintharyi Region & Kayin State
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Funding & Sponsors
Funding source category [1]
300348
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Other
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Name [1]
300348
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WHO/GMS
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Address [1]
300348
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Global Procurement
and Logistics
Block 3510
Jalan Teknokrat 6
63000 Cyberjaya
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Country [1]
300348
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Myanmar
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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), Nay Pyi Taw, Ministry of Health and Sports Office
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Country
Myanmar
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Secondary sponsor category [1]
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None
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Name [1]
299968
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Address [1]
299968
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Country [1]
299968
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301164
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Ethics Review Committee, Department of Medical Research, Ministry of Health & Sports
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Ethics committee address [1]
301164
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No (5), Ziwaka Road, Dagon Township 11191, Yangon
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Ethics committee country [1]
301164
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Myanmar
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Date submitted for ethics approval [1]
301164
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Approval date [1]
301164
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31/07/2017
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Ethics approval number [1]
301164
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Ethics/DMR/2015/118AEA/2017
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Summary
Brief summary
Title: Efficacy and safety of chloroquine for Plasmodium vivax in Kawthaung – Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy, Kayin State in Myanmar
To assess the efficacy of chloroquine against P. vivax malaria to support updating of the national policy. The study will be conducted from May to December 2017.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 chloroquine for uncomplicated P. vivax malaria and monitored for 28 days.
Febrile patients with uncomplicated P. vivax malaria attending the study clinic, who are aged 6 years and above, both sexes will be included. Total 70 patients for each specie at each study site. Clinical and parasitological parameters will be monitored over a 28 day follow-up , to evaluate the efficacy of chloroquine .
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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
86062
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Dr KAY THWE HAN
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Address
86062
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Department of Medical Research
No. 5, Ziwaka Road, Dagon Township,
Yangon 11191
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Country
86062
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Myanmar
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Phone
86062
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95 9 5169228
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Fax
86062
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95 1 251514
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Email
86062
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[email protected]
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Contact person for public queries
Name
86063
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Dr KAY THWE HAN
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Address
86063
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Department of Medical Research
No. 5, Ziwaka Road, Dagon Township,
Yangon 11191
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Country
86063
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Myanmar
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Phone
86063
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95 9 5169228
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Fax
86063
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95 1 251514
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Email
86063
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[email protected]
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Contact person for scientific queries
Name
86064
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Dr Pascal Ringwald
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Address
86064
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20 Avenue Appia
1211 Geneva 27
Switzerland
Drug efficacy and Response,
Global Malaria Program,
WHO Head quarters,
Geneva
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Country
86064
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Switzerland
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Phone
86064
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+ 41 22 7913469
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Fax
86064
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Email
86064
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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
No additional documents have been identified.
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