NCT01659281

Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand

Efficacy of Artesunate-Mefloquine Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Trat Province, Thailand

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Armed Forces Research Institute of Medical Sciences, Thailand · Other Government
• Sex: All
• Age: 5 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Plasmodium Falciparum Malaria

Interventions

Type	Name	Description
DRUG	Artesunate	6 mg/kg/day for 2 days (total dose 12 mg/kg)
DRUG	Artesunate	4 mg/kg/day for 3 days
DRUG	Mefloquine	15mg/kg at T=0 and 10 mg/kg 6-24 hours later
DRUG	Mefloquine	8 mg/kg daily for 3 days

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-05-01
• Completion: 2012-05-01
• First posted: 2012-08-07
• Last updated: 2012-08-07

Locations

1 site across 1 country: Thailand