Clinical Registration Detail

Research Registry No : CTRID-00192_V1
 
Postgraduate Research : No
 
University Departmental Research : No
 
Registration Date : 2020-02-19
 
Principle Investigator : Moe Kyaw Myint
 
Co-Investigators : Mya Moe, Phyu Phyu Win, Yi Mon Myint, Thi Thi Htun, Win Htay Hlaing, Nyein Nyein Thaung & Khin Lin
 
Title of Research : Efficacy and safety of artemether-lumefantrine and dihydroartemisinin & piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum in Ta Mu Township, Sagaing Region
 
Field of Research : Parasitology
 
Clinical Research Design : Experimental Study
 
Clinical Research Type : Applied
 
Clinical Justification : The results of this study will be used to assist the Ministry of Health and Sports, Myanmar in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria to update the treatment policy if necessary.
 
Clinical Aim : The general objective of this study is to assess the therapeutic efficacy and safety of artemether-lumefantrine and dihydroartemisininpiperaquine phosphate for the treatment of uncomplicated P. falciparum in Tamu township, Sagaing Region.
 
Clinical Objectives : • to measure the clinical and parasitological efficacy of artemether-lumefantrine and dihydroartemisinin- piperaquine phosphate for the treatment of uncomplicated P. falciparum malaria 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. The secondary objectives are: • to evaluate the incidence of adverse events; and • to determine the polymorphism of molecular markers for dihydroartemisinin-piperaquine phosphate and artemether-lumefantrine resistance
 
Clinical Sample Size : The study population will consist of patients with uncomplicated P. falciparum malaria attending the study health clinic who are aged 6 years and above except females aged 12-17 year old inclusive. Based on WHO/ERC recommendation, due to the fact that doing a pregnancy test in females between 12-17 years of age has the risk of harm to these females, without any benefits to them, this group is excluded from the study. All adult patients will sign an informed consent form for participation. Parents or guardians will give informed consent on behalf of children. Children over 12 years of age will sign an informed assent form.
 
Clinical Study Duration : : The study will be conducted from 01 July 2019 to 30 June 2020 in Tamu township, Sagaing Region
 
Clinical Study Area : Tamu township, Sagaing Region
 
Clinical Study Method : Clinical and parasitological parameters will be monitored over a 28-days and 42-days follow-up period for artemether-lumefantrine and dihydroartemisinin-piperaquine, respectively, to evaluate drug efficacy and safety of respective combinations.
 
Clinical Research Outcome : The results of this study will be used to assist the Ministry of Health and Sports, Myanmar in assessing the current national treatment guidelines for uncomplicated P. falciparum malaria to update the treatment policy if necessary.
 
Clinical Research Finding : A total of 190 malaria infections were screened from 720 blood slides examined. Among them, P.falciparum malaria were 120 and P.vivax were 70 cases. Thoses cases were investigated during July and December 2019.
 
Clinical Progress Report : Total of 63 and 62 P.falciparum cases were treated with Coartem and DHA & Ppq, respectively. Among them, 2 each from Coartem and DHA & Ppq treatment group were lost to follow-up.Among the Coartem group, 59(96.9%) and total patients treated with DHA & Ppq,
 
Study Starting Date : 2019-08-01
IRB/PRC/ERC Approval Date : 2019-05-14
 
Placement of IRB/PRC/ERC : ERC DMR, Yangon
 
IRB/PRC/ERC Approval Letter/Document : 19022020052938Ethicalclearance_2019.final.pdf
 
Pre-existing Registration ID : -
 
Pre-existing Name of Organization : -
 
Pre-existing Name of Organization Website : -