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. The study is intended to start in July 2019 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 Dihydroartemisinin piperaquine phosphate 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 Dihydroartemisinin piperaquine phosphate 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 Repsonse (ACPR) (b) Early Treatment Failure or (c) Late Treatment Failure according to the WHO guidelines. The outcome will be assessed as efficacy of the regime. (b) Presence (or) absence of side effects will be asked in each visit to assess the safety of each regime
Interventions
a non-randomized coltrol trial will be used having two arms of treatment regimes. One arm will be given Artemether-Lumefantrine regime and another arm with Dihydroartemisinin Piperaquine Phosphate for uncomplicated falciparum malaria patients. All eligible patients for the study will be enrolled. The enrolled odd numbers will be Artemether-Lumefantrine while, the even numbers will be given Dihydroartemisinin Piperaquine Phosphate regime.
Each Artemether-Lumefantrine contains artemether 20 mg and
a non-randomized coltrol trial will be used having two arms of treatment regimes. One arm will be given Artemether-Lumefantrine regime and another arm with Dihydroartemisinin Piperaquine Phosphate for uncomplicated falciparum malaria patients. All eligible patients for the study will be enrolled. The enrolled odd numbers will be Artemether-Lumefantrine while, the even numbers will be given Dihydroartemisinin Piperaquine Phosphate regime. Each Artemether-Lumefantrine contains artemether 20 mg and lumefantrine 120 mg respectively. The drug will be given as: (a) Body weight: 5-14 Kg. One tablet twice a day for three days 15-24 Kg. Two tablets twice a day for three days 25-34 Kg Three tablets twice a day for three days 35 Kg and above: Four tablets twice a day for three days Each Tablet of Dihydroartemisinin Piperaquine Phosphate contains 40mg Dihydroartemisinin and 320 mg of Piperaquine Phosphate respectively (a) Body weight: 5 to 9.9 Kg. 0,5 tablet once a day for three days 10- 19 Kg. One tablet once a day for three days 20-39 Kg Two tablets once a day for three days 40 Kg and above: Three tablets once a day for three days All tablets will be given by oral administration All the prescribed drugs will be given by the malaria staff of the township who will be recruited and trained as the member of the study team. The drugs will be administered to the patient by the malaria staff under direct observation. Also the emptied strips will be recollected by the study team.
Sponsors
World Health Organization
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
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 1000 asexual parasite count per 1 ul of blood for P falciparum malaria and 500 asexual parasite count per 1 ul of blood for P. vivax malaria
Exclusion criteria
Patients having severe and complicated malaria
Outcome results
None listed