NCT01599000

Artemether-Lumefantrine Clinical Effectiveness Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Papua New Guinea Institute of Medical Research · Other Government
• Sex: All
• Age: 6 Months – 10 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Parasitologically Confirmed; Malarial

Interventions

Type	Name	Description
DRUG	Artemether-lumefantrine combination	fixed-dose tablet, six doses over three days, according to weight group

Timeline

• Start date: 2011-03-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-05-15
• Last updated: 2012-08-16

Locations

1 site across 1 country: Papua New Guinea