Investigator(s)
| WHO Technical Officer |
Deyer Gopinath WCO Myanmar Deyer Gopinath 
|
| Principal Investigator |
Dr. Moe Kyaw Myint Parasitology Research Division, Department of Medical Research, Myanmar Dr. Moe Kyaw Myint
|
| Co-Investigator(s) |
Dr. Myat Htut Nyunt Bioinformatics Division, Advanced Molecular Research Center, Department of Medical Research, Myanmar Dr. Myat Htut Nyunt
|
| Co-Investigator(s) |
Dr. Nwe Ni Lin Vector Borne Disease Control Programme, Department of Public Health, Ministry of Health, Myanmar Dr. Nwe Ni Lin
|
Title(s) and abstract
| Scientific title | Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for Plasmodium vivax malaria in Nansang Township, Southern-Shan State, Myanmar |
| Public title | Efficacy and safety of first line treatments for uncomplicated malaria, in Nansang Township, Southern-Shan State, Myanmar |
| Background | In Myanmar currently, uncomplicated P. falciparum (P.f) malaria are treated with Artemisinin-based combination therapy (ACT). The current first line drug for P.f malaria is artemether-lumefantrine. Chloroquine is the first line drug for treatment of vivax malaria. In 2023, 81.38% were P. vivax (P.v) cases (186,004) and the rest were P. falciparum (39,021) and mixed cases (3,542). Therapeutic efficacy studies (TES) done in 2016 showed that Adequate Clinical and Parasitological Response (ACPR) to artemether-lumefantrine was 96.2 % in Mandalay Region. In 2017, ACPR of artemether-lumefantrine in Moe Nyin township, Kachin State and Naung Cho, township, Northern Shan State was 93.3% and 93.1%, respectively. For vivax malaria, the 2014 and 2015 TES results showed chloroquine efficacy against P.v malaria from 96% to 100% in 7 sites of Mandalay, Sagaing, northern and eastern Shan, Rakhine, Kachin and Thanintharyi. TES done in 2019 showed that ACPR to artemether-lumefantrine was 95.7 % in Tamu township, Sagaing Region; and for P.v malaria in 2022 in Waingmaw township, Kachin State 90.4% ACPR to chloroquine. |
| Objectives | The general objective of this study is to assess efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria and chloroquine for the treatment of P. vivax malaria in Nansang Township, Southern-Shan State, Myanmar. The primary objectives are: • to measure the clinical and parasitological efficacy of artemether-lumefantrine for the treatment of uncomplicated P. falciparum malaria and chloroquine for P. vivax in patients aged 6 years and above by determining the proportion with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy; and • to differentiate recrudescence from new infection by polymerase chain reaction (PCR) analysis for P. falciparum only The secondary objectives are: • to evaluate the incidence of adverse events; and • to determine the polymorphism of molecular markers for artemether-lumefantrine resistance. |
| Study Methods | Study Design: This surveillance study 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 artemether-lumefantrine for uncomplicated P. falciparum malaria and chloroquine phosphate for P. vivax and monitored for 28 days. Patient population: Febrile patients with uncomplicated P. falciparum and P. vivax malaria attending the study clinic, who are aged 6 years and above. Sample Size: 80 patients for each drug. Treatment(s) and follow-up: Clinical and parasitological parameters will be monitored over a 28-days follow- up period for artemether-lumefantrine for uncomplicated P. falciparum malaria and chloroquine phosphate for P. vivax, to evaluate drug efficacy and safety of respective drugs. These medicines are no more contraindicated during pregnancy including first trimester. |
| Expected outcomes and use of results | Primary endpoints: The proportion of patients with early treatment failure, late clinical failure, late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy. Recrudescence will be distinguished from re-infection by polymerase chain reaction (PCR) analysis. Secondary endpoints: • The frequency and nature of adverse events. • Polymorphism of molecular markers for artemether-lumefantrine and chloroquine drugs resistance. The results of this study will be used to assist the Ministry of Health, Myanmar in assessing the efficacy of drugs in current national treatment guidelines for uncomplicated P.f malaria and for P.v malaria and to update the treatment policy, if necessary. |
| Keywords | Treatment efficacy study (TES); Myanmar |
Research Details
| Student research | No |
| Start Date | 01-Apr-2025 |
| End Date | 31-Mar-2026 |
| Key Implementing Institution | World Health Organization |
| Multi-country research | No |
| Nationwide research | No |
| Myanmar | |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Malaria |
| Involves human subjects | Yes |
| Clinical Trial with Human Subjects | |
| Data Collection | Primary and secondary data |
| Proposal reviewed by other Committee | Final decision available |