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Artemether-Lumefantrine Clinical Effectiveness Study

NCT01599000 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2012-08-16

No results posted yet for this study

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

DRUG

Artemether-lumefantrine combination

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

Sponsors & Collaborators

  • Australian Agency for International Development

    collaborator UNKNOWN

  • National Department of Health, Papua New Guinea

    collaborator UNKNOWN

  • Papua New Guinea Institute of Medical Research

    lead OTHER_GOV

Principal Investigators

  • Manuel W Hetzel, PhD · Papua New Guinea Institute of Medical Research

  • Mueller Ivo, PhD · Walter and Eliza Hall Institute of Medical Research

  • Peter M Siba, PhD · Papua New Guinea Institute of Medical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Papua New Guinea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01599000 on ClinicalTrials.gov