Parasitologically Confirmed; Malarial Clinical Trial
Official title:
Artemether-Lumefantrine Clinical Effectiveness Study
In 2009, Papua New Guinea officially adopted artemether-lumefantrine (AL) as new national
first-line drug for uncomplicated malaria. The principal purpose of this study is to measure
the absolute effectiveness of AL when used under real-life clinical conditions, as compared
to optimized in-vivo trial conditions. This question was raised by the National Department
of Health in preparation for the country-wide roll-out of AL.
The study is designed as a randomized controlled trial comparing two study arms. Patients in
the "effectiveness arm" receive the first dose of AL under full supervision in the clinic;
the following doses will be taken at home, as in real-life clinical practice and according
to the new national treatment guidelines. Patients in the "efficacy arm" will receive all
doses of AL as directly observed treatment in the clinic in order to establish the efficacy
of the drug when used under ideal conditions.
The study will enroll outpatients aged 6 months to 10 years with a history of fever and a
positive rapid test for malaria. Patients meeting all enrollment criteria and providing full
written informed consent by a parent/caretaker will be randomized into either of the two
study arms. Patients in both arms will be followed up actively for 42 days. Patients in the
efficacy arm will be scheduled for visits on days 0, 1, 2, 3, 7, 14, 28 and 42; patients in
the effectiveness arm on days 0, 3, 7, 14, 28 and 42.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment