Health Research Registry List

Research Registry No : HRID-00192_V19
University Departmental Research : No
Registration Date : 2020-04-06
Title of Research : Treatment failures on Artemisinin-based Combination Therapies for Plasmodium falciparum in Myanmar-China and Myanmar-India border areas in 2012 and 2014
Principle Investigator : Moe Kyaw Myint
Co-authors : Charlotte Rasmussen, Aung Thi, Dorina Bustos, Pascal Ringwald and Khin Lin
Field of Research : Parasitology
Publication Source : ” Malaria Journal, 2017. Apr 7;16 (1): 143
Year of Publication : 2017
URL of Publication : -
Presentation Source : 45th Myanmar Health Research Congress, 2017; P24
Placement of Presentation : DMR Yangon
Year of Presentation : 2017
Abstract : BACKGROUND: In Myanmar, three types of artemisinin-based combination therapy (ACT) are recommended as first-line treatment of uncomplicated falciparum malaria: artemether-lumefantrine (AL), artesunate-mefloquine (AS + MQ), and dihydroartemisinin-piperaquine (DP). Resistance to both artemisinins and ACT partner drugs has been reported from the Greater Mekong Sub-region, and regular efficacy monitoring of the recommended ACT is conducted in Myanmar. This paper reports on results from studies to monitor the efficacy of the three forms of ACT in sentinel sites in northern Myanmar, and investigations of mutations in the Kelch13 (k13) propeller domain. METHODS: Seven therapeutic efficacy studies were conducted in 2011-12 and 2014 in three sentinel sites in Myanmar (Tamu, Muse, Tabeikkyin). Three studies were done for the evaluation of AL (204 patients), two studies for AS + MQ (119 patients) and two studies for DP (147 patients). These studies were done according to 2009 standard WHO protocol. Polymorphisms in the k13 propeller domain were examined in dried blood spots collected on day 0. The primary endpoint was adequate clinical and parasitological response (ACPR) on day 28 for AL and on day 42 for DP and AS + MQ, corrected to exclude re-infection using polymerase chain reaction (PCR) genotyping. Safety data were collected through self-reporting. RESULTS: PCR-corrected ACPR was 97.2-100% for AL, 98.6-100% for AS + MQ and 100% for DP across the study sites and years. All studies found a prevalence of k13 mutations (>440) above 23% in the day-0 samples. The F446I mutation was the most common mutation, making up 66.0% of the mutations found. Seven out of nine day-3 positive patients were infected with k13 wild type parasites. The remaining two cases with day-3 parasitaemia had the P574L mutation. CONCLUSIONS: The efficacy of AL, AS + MQ and DP remains high in northern Myanmar despite widespread evidence of k13 mutations associated with delayed parasite clearance. This study showed that already in 2012 there was a high frequency of k13 mutations in Myanmar on the border with India. The high efficacy of the recommended ACT gives confidence in the continued recommendation of the use of these treatments in Myanmar.
IRB/PRC/ERC Approval Date : 2015-08-17
Placement of IRB/PRC/ERC : ERC DMR Yangon
IRB/PRC/ERC Approval Letter/Document : 06042020023135img-403164021.pdf
Pre-existing Registration ID : -
Pre-existing Name of Organization : -
Pre-existing Website : -