None listed
Conditions
Brief summary
The study will be done in Ta-mu township, Sagaing Region which is located in the norther-west part of the country along the Myanmar-India border. It is regarded as the sentinel site by WHO to monitor the drug resistance malaria in the region as there is a lot of population migration along the two countries. The activity of monitoring the drug resistance malaria has been started since 2009 in this area. In 2018, the study is intended to start in the September where clinically suspected malaria patients will be tested using Giemsa stained microscopic examination. Patients having asexual malaria parasites 1000 per micro-liter and above will be enrolled and given either artemether-lumefantrine or pyronaridine-artesuante regimes, which are the standard ACTs and regarded as standard regimes by the Ministry of Health and Sports. The patients will be followed up on days 2,3 and every week up to for 28 days for artemether-lumefantrine group (or) 42 days for those treated with pyronaridine-artesunate regime. The clinical symptoms will also be recorded during the visits and blood will be tested by microscopic examination as well as by filter papers for PCR test. Then findings will be classified as (a) Adequate Clinical and Parasitological Resonse (ACPR) (b) Early Treatment Failure or (c) Late Treatment Failure according to the WHO guidelines.
Interventions
a non-randomized control trial will be used having two arms of treatment regimes. One arm will be given artemether-lumefantrine (A-L)and another with pyronaridine-artesunate (P-A) for falciparum malaria. For vivax malaria only one arm, pyronaridine-artesunate will be administered.
All patients eligible for the study will be enrolled.The odd numbers will be treated with A-L, while the even numbers will be treated with P-A.
Each artemether-lumefantrine tablet consists as 20 mg : 120 mg respective
a non-randomized control trial will be used having two arms of treatment regimes. One arm will be given artemether-lumefantrine (A-L)and another with pyronaridine-artesunate (P-A) for falciparum malaria. For vivax malaria only one arm, pyronaridine-artesunate will be administered. All patients eligible for the study will be enrolled.The odd numbers will be treated with A-L, while the even numbers will be treated with P-A. Each artemether-lumefantrine tablet consists as 20 mg : 120 mg respectively. artemether-lumefantrine will be given as follows: (a) Body weight having 5-14 Kg. one tablet twice a day for three days (b) Body weight having 15-24 Kg. two tablets twice a day for three days (c) Body weight having 24-35 Kg. three tablets twice a day for three days (d) Body weight having 35 Kg and above: four tablets twice a day for three days Each tablet of pyronaridine : artesunate composed as 180 mg and 60 mg respectivelt Pyronaridine-artesunate will be given as follows: (a) 15-19 Kg. body weight: half tablet once a day for three days (b) 20-24 Kg. body weight: one tablet once a day for three days (c) 25-44 Kg. body weight : two tablets once a day for three days (d) 45-64 Kg. body weight: three tablets once a day for three days (e) 65 Kg. and above: four tablets once a day for three days All tablets will be given by oral administration
Sponsors
WHO country office
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Patients having fever with a parasitological count of more than 1000 asexual parasites per 1 ul of blood for P.falciparum malaria and 500 asexual parasites per 1 ul for P. vivax malaria
Exclusion criteria
Patients having severe and complicated malaria
Outcome results
None listed