Study of Malaria Treatment at Phuoc Long Hospital, Binh Phuoc Province, Vietnam
Status:
Completed
Trial end date:
2011-05-01
Target enrollment:
Participant gender:
Summary
Background: There are worrying signs from Western Cambodia that parasitological responses to
artesunate containing treatment regimens for uncomplicated falciparum malaria are slower than
elsewhere in the world. Delayed parasite clearance and unusually high failure rates with
artesunate-mefloquine have been reported. These antimalarials are central to current
treatment strategies and spread of significant resistance outside this area would be a global
disaster. Radical containment measures are needed. In this context there is an urgent need to
proceed quickly to investigate whether there is any evidence of resistance to artemisinin
derivatives in Vietnam.
Objective: The primary objective is to assess the slope of the decline in the log
parasitemia-time curve in patients treated with artesunate 2mg/kg/day, artesunate 4mg/kg/day
or dihydroartemisinin-piperaquine once daily, and to compare the results of this study to the
pharmacokinetic results and to the recent data from patients in Cambodia and Thailand treated
with equivalent therapies.
Methods: The trial will be conducted in Phuoc Long Hospital, Binh Phuoc Province, Vietnam.
The participants will be febrile patients (aged > 10 years) with slide confirmed
uncomplicated P. falciparum infection. Patients will be treated with either artesunate
2mg/kg/day, artesunate 4mg/kg/day or dihydroartemisinin-piperaquine once daily for 3 days.
Patients on artesunate therapy arms will then receive 3 days of treatment with
dihydroartemisinin-piperaquine with dosages according to the national guidelines. Clinical
and parasitological parameters will be monitored over a 42-day follow-up period. The
pharmacokinetic characteristics of artesunate and dihydroartemisinin will be assessed by
using a population pharmacokinetic modeling.