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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
Scientific title
Efficacy and safety of chloroquine for Plasmodium vivax in Kawthaung –Mawhtaung, Tanintharyi Region and Kyainseikkyi-Myawaddy, Kayin State in Myanmar.
Secondary ID [1] 295758 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 309157 0
Fever 309158 0
Headache 309373 0
Anaemia 309375 0
Condition category
Condition code
Infection 308239 308239 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 312089 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307029 0
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
Timepoint [1] 307029 0
At the end of follow up 28 days (follow up visits on day 3, day 7, day 14, day 21, day 28),
Secondary outcome [1] 350427 0
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.
Timepoint [1] 350427 0
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.

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
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Budgeting period is over.
Date of first participant enrolment
Anticipated
Actual
15/08/2017
Date of last participant enrolment
Anticipated
Actual
1/11/2017
Date of last data collection
Anticipated
Actual
25/12/2017
Sample size
Target
140
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 20735 0
Myanmar
State/province [1] 20735 0
Tanintharyi Region & Kayin State

Funding & Sponsors
Funding source category [1] 300348 0
Other
Name [1] 300348 0
WHO/GMS
Country [1] 300348 0
Myanmar
Primary sponsor type
Government body
Name
Ministry of Health and Sports
Address
Office Number (4), Nay Pyi Taw, Ministry of Health and Sports Office
Country
Myanmar
Secondary sponsor category [1] 299968 0
None
Name [1] 299968 0
Address [1] 299968 0
Country [1] 299968 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301164 0
Ethics Review Committee, Department of Medical Research, Ministry of Health & Sports
Ethics committee address [1] 301164 0
Ethics committee country [1] 301164 0
Myanmar
Date submitted for ethics approval [1] 301164 0
Approval date [1] 301164 0
31/07/2017
Ethics approval number [1] 301164 0
Ethics/DMR/2015/118AEA/2017

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

Contacts
Principal investigator
Name 86062 0
Dr KAY THWE HAN
Address 86062 0
Department of Medical Research
No. 5, Ziwaka Road, Dagon Township,
Yangon 11191
Country 86062 0
Myanmar
Phone 86062 0
95 9 5169228
Fax 86062 0
95 1 251514
Email 86062 0
[email protected]
Contact person for public queries
Name 86063 0
KAY THWE HAN
Address 86063 0
Department of Medical Research
No. 5, Ziwaka Road, Dagon Township,
Yangon 11191
Country 86063 0
Myanmar
Phone 86063 0
95 9 5169228
Fax 86063 0
95 1 251514
Email 86063 0
[email protected]
Contact person for scientific queries
Name 86064 0
Pascal Ringwald
Address 86064 0
20 Avenue Appia
1211 Geneva 27
Switzerland
Drug efficacy and Response,
Global Malaria Program,
WHO Head quarters,
Geneva
Country 86064 0
Switzerland
Phone 86064 0
+ 41 22 7913469
Fax 86064 0
Email 86064 0
[email protected]

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

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