The main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria.
This will be a randomized, open-label comparison of two versus three days artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. Primary endpoints will be 63-day parasitological cure rates in the 2 treatment groups. Secondary endpoints will be parasitological failure rates at each of the weekly follow-up visits to Day 56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite isolates as measured by inhibitory concentrations. Genotyping of parasites for known markers of drug resistence will be performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
13
6 mg/kg/day for 2 days (total dose 12 mg/kg)
4 mg/kg/day for 3 days
15mg/kg at T=0 and 10 mg/kg 6-24 hours later
Vector Borne Diseases Control Units (VBDC, malaria clinics)
Borai, Khaosaming and Muang Districts, Changwat Trat, Thailand
Determination of parasitological cure rate of directly observed antimalarial therapy
Time frame: 63 days from initiation of treatment
Parasitological cure rates
Time frame: Weekly to Day 56
Occurence of treatment-emergent adverse events
Time frame: 3 days
In vitro drug sensitivity profile for individual parasite isolates
Time frame: Baseline
Mefloquine whole blood concentrations
Time frame: 28 days
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8 mg/kg daily for 3 days