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.

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Key information

Conditions

Parasitologically Confirmed; Malarial Infections Malaria Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

6 month–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gurney Health Centre

Alotau, Milne Bay Province, Papua New Guinea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 6 months to 10 years (+/- 1 month for children without known date of birth)
Permanent resident in the study area
Not enrolled in another study at the same time
No known history of hypersensitivity reactions to artemether or lumefantrine
History of fever in the previous 72 hours (approximate)
Rapid diagnostic test (RDT) positive for any species of Plasmodium

Exclusion criteria

General danger signs: inability to drink or breastfeed, vomiting everything, recent history of convulsions, lethargy or unconsciousness, inability to sit or stand up
Signs of severe malaria (impaired consciousness, respiratory distress, circulatory collapse, abnormal bleeding, jaundice, or as determined by clinician)
Severe malnutrition: defined as a child whose weight-for-height is below -3 standard deviation or less than 70% of the median of the NCHS/WHO normalized reference values, or who has symmetrical oedema involving at least the feet; or middle upper arm circumference under 12 cm
Clinically significant concomitant disease requiring admission
Contraindications mentioned in the national treatment guidelines

Treatment and study plan

Artemether-lumefantrine combination

Drug

fixed-dose tablet, six doses over three days, according to weight group

Other names: Coartem, Novartis

Primary outcomes

Adequate Clinical and Parasitological Response (ACPR)

Time frame: 42 days

ACPR = Absence of parasitemia on Day 42 irrespective of axillary temperature without previously meeting any of the criteria of Early Treatment Failure or Late Clinical Failure or Late Parasitological Failure (adapted from WHO 2003).

Sponsors and collaborators

Lead sponsor

Papua New Guinea Institute of Medical Research

Other Gov

Collaborators

Australian Agency for International Development
National Department of Health, Papua New Guinea

Registry information

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2012
First posted: May 15, 2012
Registry last updated: Aug 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed