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In Vivo Efficacy of Artemether-Lumefantrine and Artesunate-Amodiaquine for Uncomplicated P. Falciparum Malaria

NCT02637128 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 452

Last updated 2015-12-22

No results posted yet for this study

Summary

This study was designed to determine the efficacy of both artemether-lumefantrine and artesunate-amodiaquine (but not to compare the efficacies of the two drugs) for the treatment of uncomplicated Plasmodium falciparum malaria at Machinga, Nkhotakota, and Karonga District Hospitals- Malawi.

Conditions

  • MALARIA, FALCIPARUM

Interventions

DRUG

artemether-lumefantrine (AL)

Dispersible formulation of artemether-lumefantrine (Coartem-D™; 20mg artemether/120mg lumefantrine per tablet, Novartis, Switzerland) administered twice a day for 3 days according to manufacturer recommended dosing for weight

DRUG

artesunate-amodiaquine (ASAQ)

Co-formulated artesunate-amodiaquine (25mg artesunate/67.5mg amodiaquine and 50mg artesunate/135mg amodiaquine tablets) administered once a day for 3 days, according to manufacturer recommended dosing for weight

Sponsors & Collaborators

Principal Investigators

  • Don P Mathanga, MBBS, PhD · 1. Malaria Alert Centre (MAC), University of Malawi College of Medicine, Blantyre, Malawi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Malawi

Study Locations

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Entities

Companies

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 NCT02637128 on ClinicalTrials.gov