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

Plasmodium Falciparum Malaria Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

• NCT number: NCT01659281
• Study type: Interventional
• Source: Armed Forces Research Institute of Medical Sciences, Thailand
• Status: Completed
• Phase: N/A
• Start date: September 2007
• Completion date: May 2012