Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001476224
Ethics application status
Approved
Date submitted
18/07/2018
Date registered
4/09/2018
Date last updated
6/08/2019
Date data sharing statement initially provided
6/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of (a) A-Lfor Plasmodium falciparum and (b) P-A for Plasmodium falciparum and Plasmodium vivax malaria in Ta-mu Township, Sagaing Region
Scientific title
Study on clinical and parasitological outcome of (a) ACT, A-L for falciparum malaria and (b) P-A for falciparum and vivax malaria in Ta-mu township, Sagaing Region
Secondary ID [1] 295663 0
nil
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
malaria related fever 308882 0
headache 308883 0
ache 308884 0
mailaise 309100 0
loss of appetite 309101 0
Condition category
Condition code
Public Health 307793 307793 0 0
Other public health
Infection 307978 307978 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
a non-randomized control trial will be used having two arms of treatment regimes. One arm will be given artemether-lumefantrine (A-L)and another with pyronaridine-artesunate (P-A) for falciparum malaria. For vivax malaria only one arm, pyronaridine-artesunate will be administered.
All patients eligible for the study will be enrolled.The odd numbers will be treated with A-L, while the even numbers will be treated with P-A.

Each artemether-lumefantrine tablet consists as 20 mg : 120 mg respectively.
artemether-lumefantrine will be given as follows:
(a) Body weight having 5-14 Kg. one tablet twice a day for three days
(b) Body weight having 15-24 Kg. two tablets twice a day for three days
(c) Body weight having 24-35 Kg. three tablets twice a day for three days
(d) Body weight having 35 Kg and above: four tablets twice a day for three days
Each tablet of pyronaridine : artesunate composed as 180 mg and 60 mg respectivelt
Pyronaridine-artesunate will be given as follows:
(a) 15-19 Kg. body weight: half tablet once a day for three days
(b) 20-24 Kg. body weight: one tablet once a day for three days
(c) 25-44 Kg. body weight : two tablets once a day for three days
(d) 45-64 Kg. body weight: three tablets once a day for three days
(e) 65 Kg. and above: four tablets once a day for three days

All tablets will be given by oral administration
Intervention code [1] 301882 0
Treatment: Drugs
Comparator / control treatment
For falciparum malaria, currently using artemether-lumefantrine will be used as a control regime. There is no control drug for vivax malaria.
Control group
Active

Outcomes
Primary outcome [1] 306777 0
Adequate Clinical and Parasitological Response (ACPR)
Blood smears will be taken on days 1,2,3,7,14,21,and 28 days after the initial treatment.
Each follow-up will consist of clinical assessment, body temperature and microscopic examination of Giemsa stained thick blood smear
(Tympanic temperature will be assessed by using digital thermometer to a one decimal number))
( malaria parasites will be identified and counted by Giemsa stained thick smear microscopic examination. Two qualified laboratory technicians will check the blood smears. If the difference between the two reading results are more than 10%, third reader will be invited for confirmation of the findings.).
Timepoint [1] 306777 0
28 days from enrollment
Primary outcome [2] 306974 0
Early Treatment Failure (ETF)
If the patient have severe signs and symptoms of malaria within three days of initial treatment
(or) Fever persist after three days of treatment (Tympanic temperature will be assessed by using digital thermometer to a one decimal number))
(or) Malaria asexual parasites remain after three days of treatment ( malaria parasites will be identified and counted by Giemsa stained thick smear microscopic examination. Two qualified laboratory technicians will check the blood smears. If the difference between the two reading results are more than 10%, third reader will be invited for confirmation of the findings.).
Timepoint [2] 306974 0
Three days after initial treatment
Secondary outcome [1] 349595 0
Late Treatment Failure (LTF)
It is assessed after 4-28 days of treatment by
(a) General conditions.
Medical officer will perform clinical examination: level of consciousness, inspection of anemia (pallor) , measuring heart rate, respiration, blood pressure . He will ask if there is presence of vomiting, diarrhea or other illness.
(b) Body temperature assessment(Tympanic temperature will be assessed by using digital thermometer to a one decimal number))
(c) Asexual malaria parasites counting by microscopic examination of Giemsa stained thick blood smear..( malaria parasites will be identified and counted by Giemsa stained thick smear microscopic examination. Two qualified laboratory technicians will check the blood smears. If the difference between the two reading results are more than 10%, third reader will be invited for confirmation of the findings.).
Timepoint [1] 349595 0
4-28 days after the initial treatment

Eligibility
Key inclusion criteria
Patients having fever with a parasitological count of more than 1000 asexual parasites per 1 ul of blood for P.falciparum malaria and 500 asexual parasites per 1 ul for P. vivax malaria
Minimum age
6 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients having severe and complicated malaria

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)
Allocation is not concealed.
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
Other design features
P.falciparum malaria will be treated with either AL (or) P-A, while all P.vivax malaria patients will be treated with P=A.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Number of minimum patients needed to be calculated according to the WHO therapeutic efficacy treatment guidelines.
Data obtained will be entered, cleaned and analyzed according to the Standard excel template developed by WHO.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/10/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2018
Actual
Date of last data collection
Anticipated
31/01/2019
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 10727 0
Myanmar
State/province [1] 10727 0
Sagaing Region

Funding & Sponsors
Funding source category [1] 300161 0
Other Collaborative groups
Name [1] 300161 0
World Health Organization
Country [1] 300161 0
Myanmar
Primary sponsor type
Other Collaborative groups
Name
WHO country office
Address
No. 403 A,
Shwe Taung Kyar Street,
Bahan Township,
YANGON Region
MYANMAR
Country
Myanmar
Secondary sponsor category [1] 299568 0
None
Name [1] 299568 0
nil
Address [1] 299568 0
nil
Country [1] 299568 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300993 0
Ethics Review Committee, Department of Medical Research
Ethics committee address [1] 300993 0
Department of Medical Research
No.5, Ziwaka Road,
Dagon Township,
YANGON 11191
MYANMAR
Ethics committee country [1] 300993 0
Myanmar
Date submitted for ethics approval [1] 300993 0
22/02/2018
Approval date [1] 300993 0
12/04/2018
Ethics approval number [1] 300993 0
002716

Summary
Brief summary
The study will be done in Ta-mu township, Sagaing Region which is located in the norther-west part of the country along the Myanmar-India border.
It is regarded as the sentinel site by WHO to monitor the drug resistance malaria in the region as there is a lot of population migration along the two countries. The activity of monitoring the drug resistance malaria has been started since 2009 in this area.
In 2018, the study is intended to start in the September where clinically suspected malaria patients will be tested using Giemsa stained microscopic examination. Patients having asexual malaria parasites 1000 per micro-liter and above will be enrolled and given either artemether-lumefantrine or pyronaridine-artesuante regimes, which are the standard ACTs and regarded as standard regimes by the Ministry of Health and Sports. The patients will be followed up on days 2,3 and every week up to for 28 days for artemether-lumefantrine group (or) 42 days for those treated with pyronaridine-artesunate regime. The clinical symptoms will also be recorded during the visits and blood will be tested by microscopic examination as well as by filter papers for PCR test. Then findings will be classified as
(a) Adequate Clinical and Parasitological Resonse (ACPR) (b) Early Treatment Failure or (c) Late Treatment Failure according to the WHO guidelines.
Trial website
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 85534 0
Dr KHIN LIN
Address 85534 0
Department of Medical Research
Ward No. (10), Pyin Oo Lwin township
Mandalay Region
MYANMAR
Country 85534 0
Myanmar
Phone 85534 0
095-0943151627
Fax 85534 0
095-8520-50251
Email 85534 0
dr.khinlin.dir@gmail.com
Contact person for public queries
Name 85535 0
Dr KHIN LIN
Address 85535 0
Department of Medical Research
Ward No. (10), Pyin Oo Lwin township
Mandalay Region
MYANMAR
Country 85535 0
Myanmar
Phone 85535 0
095-08520-50436
Fax 85535 0
095-8520-50251
Email 85535 0
dr.khinlin.dir@gmail.com
Contact person for scientific queries
Name 85536 0
Dr KHIN LIN
Address 85536 0
Department of Medical Research
Ward No. (10), Pyin Oo Lwin township
Mandalay Region
MYANMAR
Country 85536 0
Myanmar
Phone 85536 0
095-08520-50436
Fax 85536 0
095-8520-50251
Email 85536 0
dr.khinlin.dir@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.