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Trial registered on ANZCTR


Registration number
ACTRN12618001952235
Ethics application status
Approved
Date submitted
5/09/2018
Date registered
3/12/2018
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
3/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy and safety of Artemether-Lumefantrine (A-L) for P.falciparum malaria and Pyronaridine-Artesunate (P-A) for treatment of uncomplicated Plasmodium falciparum malaria and P. vivax malaria in Myit Kyi Nar township, Kachin state and Kyauk Mee township, Northern Shan state
Scientific title
Testing efficacy and safety of A-L for falciparum malaria and P-A for falciparum and vivax malaria in Myit KyiNar township, Kachin state and Kyauk Mee township, Northern Shan state
Secondary ID [1] 295596 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
malaria 308911 0
Condition category
Condition code
Infection 307815 307815 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Non- randomized controlled trial for falciparum malaria, where one arm was given A-L and the second arm was given P-A .
All falciparum patients who met the inclusion criteria were enrolled.
Odd numbers were given A-L which was given as oral tablets twice a day for three according to the dosing chart.
A-L ( each tablet contains 20 mg artemether & 120 mg lumefantrine) was given according to the body weight as:
(a) 15-24 Kg.body weight: two tablets twice a day for three days
(b) 25-34 Kg.body weight: three tablets twice a day for three days
(c) 35 and above: four tablets twice a day for three days
Even numbers were administered oral P-A tablet ( each tablet contains Pyronaridine 60 mg & artesunate 20 mg) was given according to the body weight as:
(a) 20-24 Kg.body weight: one tablet three times a day for three days
(b) 25-44 Kg.body weight: two tablets three a day for three days
(c) 45 - 65 Kg. body weight : three tablets three times a day for three days
Adherence of treatment was monitored by asking to show the the empty drug card in the follow up visits.
Patients having P.vivax as detected ny microscopic examination were treated with P-A while the dosage was the same for P. falciparum malaria.

Intervention code [1] 301896 0
Treatment: Drugs
Comparator / control treatment
A-L combination was compared with P-A Combination for treatment of uncomplicated falciparum malaria
Control group
Active

Outcomes
Primary outcome [1] 306798 0
Adequate Clinical and Parasitological Response (ACPR)
Assessment was done by measuring body temperature ( tympanic temperature) using digital thermometer. and microscopic examination of Giemsa stained blood smear (thick film)..
If body temperature reaches 37 C on day 3 and no presence of fever throughout the follow-up up to 42 days and
Asexual malaria parasites are absent on day 3 and disappearance throughout the follow-up visits by microscopic examination, the patient is categorized as Adequate Clinical and Parasitological Response (ACPR)
Timepoint [1] 306798 0
28 days post treatment
Patient was treated on Day 0 and follow up was done on Day 1,,2,,3, 7, 14, 21 and 28 days respectively
Secondary outcome [1] 349676 0
Early Treatment Failure ETF
Assessment was done by measuring body temperature ( tympanic temperature) using digital thermometer. and microscopic examination of Giemsa stained blood smear (thick film)..
If the patient has body temperature more than 37.5 C on day 3 (or)
If asexual parasites still appear on bay 3 by microscopic examination
Timepoint [1] 349676 0
28 days
Patient was treated on Day 0 and follow up was done on Day 1,,2,,3, 7, 14, 21 and 28 days respectively

Eligibility
Key inclusion criteria
For Plasmodium falciparum malaria
Patients having asexual parasites of Plasmodium falciparum between 1000-100000 per micro-liter in blood
Patients having ages of six years and above will be included
Patients who do not have signs and symptoms of severe and complicated malaria
Patients who do not have known chronic diseases: Tuberculosis, HIV/AIDS, Malignancies
Patients who have not anti-malarials in the past 14 days
For Plasmodium vivax malaria
Patients having asexual parasites of Plasmodium vivax at least 500-50,000 per micro-liter in blood
Patients having ages of six years and above will be included
Patients who do not have signs and symptoms of severe and complicated malaria
Patients who do not have known chronic diseases: Tuberculosis, HIV/AIDS, Malignancies
Patients who have not anti-malarials in the past 14 days
P-A was studies for both P.falciparum and P..vivax malaria, while A-L was studies only for P. falciparum malaria

Minimum age
6 Years
Maximum age
No limit
Gender
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 was 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
Parallel
Other design features
nil
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Minimal sample size was calculated according to the standard WHO criteria. The findings were analyzed using standard WHO excel template

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10669 0
Myanmar
State/province [1] 10669 0
Kachin and Northern Shan States

Funding & Sponsors
Funding source category [1] 300174 0
Other
Name [1] 300174 0
WHO country office for Myanmar
Address [1] 300174 0
No. 4013 A,
Shwe Taung Kyar Street
Bahan township, 11201
Yangon Region
MYANMAR
Country [1] 300174 0
Myanmar
Primary sponsor type
Other
Name
WHO country office
Address
No. 4013 A,
Shwe Taung Kyar Street
Bahan township, 11201
Yangon Region
MYANMAR
Country
Myanmar
Secondary sponsor category [1] 299583 0
Government body
Name [1] 299583 0
Department of Public Health
Address [1] 299583 0
Department of Public Health
Ministry of Health and Sports
Ward (4)
Nay Pyi Taw
MYANMAR
Country [1] 299583 0
Myanmar
Other collaborator category [1] 280250 0
Government body
Name [1] 280250 0
Vector Borne Diseases Control Programme
Address [1] 280250 0
Vector Borne Diseases Control Programme
Diseases Control Compound
Department of Public Health
Ministry of Health and Sports
Ward (4)
Nay Pyi Taw
MYANMAR
Country [1] 280250 0
Myanmar

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301006 0
Ethics Review Committee, Department of Medical Research
Ethics committee address [1] 301006 0
Department of Medical Research
No.5 Ziwaka Street,
Dagon Township
Yangon 11191
MYANMAR
Ethics committee country [1] 301006 0
Myanmar
Date submitted for ethics approval [1] 301006 0
12/02/2017
Approval date [1] 301006 0
24/04/2017
Ethics approval number [1] 301006 0
002716

Summary
Brief summary
The study aimed to assess efficacy and side effects of two ACTs for treatment of uncomplicated falciparum malaria using WHO standard protocol in two sentinel sites of Upper Myanmar..
Trial website
Trial related presentations / publications
nil
Public notes
nil

Contacts
Principal investigator
Name 85574 0
Dr KHIN LIN
Address 85574 0
Department of Medical Research
Ward (10), Pyin Oo Lwin township
Mandalay Region
MYANMAR
Country 85574 0
Myanmar
Phone 85574 0
+95-08520-50436
Fax 85574 0
+95-08520-50525
Email 85574 0
dr.khinlin.dir@gmail.com
Contact person for public queries
Name 85575 0
Dr KHIN LIN
Address 85575 0
Department of Medical Research
Ward (10), Pyin Oo Lwin township
Mandalay Region
MYANMAR
Country 85575 0
Myanmar
Phone 85575 0
+95-08520-50436
Fax 85575 0
+95-08520-50525
Email 85575 0
dr.khinlin.dir@gmail.com
Contact person for scientific queries
Name 85576 0
Dr KHIN LIN
Address 85576 0
Department of Medical Research
Ward (10), Pyin Oo Lwin township
Mandalay Region
MYANMAR
Country 85576 0
Myanmar
Phone 85576 0
+95-08520-50436
Fax 85576 0
+95-08520-50250
Email 85576 0
dr.khinlin.dir@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 47 0
Ethical approval
Citation [1] 47 0
Link [1] 47 0
Email [1] 47 0
Other [1] 47 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Both A-L and P-A are efficacious for treatment of uncomplicated falciparum malaria while P-A is also for vivax malaria