Clinical Registration Detail

Research Registry No : CTRID-00192_V2
 
Postgraduate Research : No
 
University Departmental Research : No
 
Registration Date : 2022-01-20
 
Principle Investigator : Moe Kyaw Myint
 
Co-Investigators : Toe Aung, Mya Moe, Phyu Phyu Win, Nay Yi Yi Lin & Khin Lin
 
Title of Research : "Efficacy and safety of (a) Artemether-lumefantrine for the treatment of uncomplicated P.f and Chloroquine for P.v malaria in Homalin Township, Sagaing Region (b) Dihydroartemisinin-Piperaquine phosphate for the treatment of P.f malaria in Moemeik dist
 
Field of Research : Parasitology
 
Clinical Research Design : Experimental Study
 
Clinical Research Type : Applied
 
Clinical Justification : The recommended ACTs for treatment of uncomplicated falciparum malaria in Myanmar are: (a) artemether-lumefantrine (b) Dihydroartemisinin-piperaquine combination and (c) artesunate-mefloquine combination. Therapeutic efficacy studies done in 2019 showed that Adequate Clinical and Parasitological Response (ACPR) to artemther - lumefantrine and dihydroartemisinin-piperaquine phosphate were 95.7 % and 100 % in Tamu township, Saggaing Region. The results of this study will be used to assist the Ministry of Health and Sports, Myanmar in assessing the efficacy of current national treatment guidelines for uncomplicated P. falciparum malaria and to update the treatment policy if necessary.
 
Clinical Aim : To assess efficacy and safety of Artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria and Chloroquine for P. vivax malaria to support updating of the national treatment policy
 
Clinical Objectives : The general objective of this study is to assess efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment of P. vivax malaria.
 
Clinical Sample Size : The study population will consist of 60 patients each with uncomplicated P. falciparum and P. vivax malaria attending the study health clinic who are aged 6 years and above except unmarried females and females aged 12-17 year old inclusive.
 
Clinical Study Duration : The study will be conducted from 01 January 2022 to 31 December 2022.
 
Clinical Study Area : Homalin Township, Sagaing Region and Moe Meik district in Northern Shan State.
 
Clinical Study Method : This surveillance study is a one arm prospective evaluation of clinical and parasitological responses to directly observed treatment for uncomplicated falciparum and vivax malaria. People with uncomplicated malaria who meet the study inclusion criteria will be enrolled, treated on site with artemether-lumefantrine (AL) for uncomplicated P. falciparum malaria and monitored for 28 days and chloroquine for P. vivax malaria and monitored for 28 days.
 
Clinical Research Outcome : The results of this study will be used to assist the Ministry of Health and Sports, Myanmar in assessing the efficacy of current national treatment guidelines for uncomplicated P. falciparum malaria and to update the treatment policy if necessary.
 
Clinical Research Finding : The study is on-going status. ERC approval was just obtained and funding in waiting. Advocacy meeting with NMCP of MOH was done.
 
Clinical Progress Report : The proposal was submitted to WHO ERC and IRB DMR. Approval certificates from both WHO ERC and IRB DMR were released.
 
Study Starting Date : 2022-01-01
IRB/PRC/ERC Approval Date : 2021-12-31
 
Placement of IRB/PRC/ERC : IRB-DMR
 
IRB/PRC/ERC Approval Letter/Document : 20012022034404IRBTESExtendupto2022byDMR.pdf
 
Pre-existing Registration ID : No
 
Pre-existing Name of Organization : Department of Medical Research (Pyin Oo Lwin Branch)
 
Pre-existing Name of Organization Website : Director (Planning) Department of Medical Research (Pyin Oo Lwin Branch)