Drug efficacy testing is one of the most important tasks that is routinely undertaken by the National Malaria Control Program (NMCP) in Tanzania and has been recommended by the World health Organisation to monitor the efficacy of artemisinin based combination therapy (ACT) and possibly detect evolution/emergency of tolerance/resistance to these drugs. Currently, Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment guidelines as the second line drug for the treatment of uncomplicated malaria in the country.
Currently, Artemether-lumefantrine (ALu) is the only ACT recommended by the Ministry of Health and Social Welfare and therefore testing of new ACTs such as dihydroartemisinin-piperaquine (DHA-PQ) is important because alternative drugs are urgently required. Meanwhile, NMCP is revising the guidelines for treatment of malaria in Tanzania and DHA-PQ has been earmarked as an alternative ACT to be used together with ALu. However, efficacy and safety data of DHA-PQ is missing since no studies have been done in Tanzania. Thus, a study is proposed to assess the efficacy and safety of DHA-PQ Vs ALu and provide important data which will enable the NMCP to make informed decisions; and possibly recommend DHA-PQ in the new Malaria treatment guidelines as the second line drug for the treatment of uncomplicated malaria in the country.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
509
Artemether-lumefantrine
Dihydroartemisinin-piperaquine
Ujiji Health Centre
Ujiji, Kigoma Region, Tanzania
Muheza Disignated District Hospital
Muheza, Tanga, Tanzania
parasitological cure on day 28 for ALu and 42 for DHA-PQ
non-adjusted and adjusted by PCR to account for new infections.
Time frame: 42 days
parasite clearance after 72 hours.
Microscope Blood slide for malaria reading 0 parasite.
Time frame: 72 hours
parasitological cure on day 14
Microscope Blood slide for malaria reading 0 parasite.
Time frame: 14 days
extended parasitological cure on day 42 for ALu and 63 for DHA-PQ
PCR and Microscope Blood slide for malaria parasitemia reading 0.
Time frame: 63 days
improvement in haemoglobin level at day 28 from the day 0 baseline
Time frame: 28 days
reduction in gametocyte carriage at day 14 and day 28 from the day 0 baseline,
Time frame: 28 days
occurrence and severity of adverse events and genomic profile of P.falciparum.
Time frame: 63 days
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