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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy and safety of artemether-lumefantrine dispersible tablets compared with crushed commercial tablets in African infants and children with uncomplicated malaria: a randomised, single-blind, multicentre trial
The Lancet, Volume 372, No. 9652, Year 2008
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Description
Background: Combination treatments, preferably containing an artemisinin derivative, are recommended to improve efficacy and prevent Plasmodium falciparum drug resistance. Our aim was to show non-inferiority of a new dispersible formulation of artemether-lumefantrine to the conventional crushed tablet in the treatment of young children with uncomplicated malaria. Methods: We did a randomised non-inferiority study on children weighing 5-35 kg with uncomplicated P falciparum malaria in Benin, Kenya, Mali, Mozambique, and Tanzania. The primary outcome measure was PCR-corrected 28-day parasitological cure rate. We aimed to show non-inferiority (with a margin of -5%) of dispersible versus crushed tablet. We constructed an asymptotic one-sided 97·5% CI on the difference in cure rates. A computer-generated randomisation list was kept centrally and investigators were unaware of the study medication administered. We used a modified intention-to-treat analysis. This trial is registered with ClinicalTrials.gov, number NCT00386763. Findings: 899 children aged 12 years or younger were randomly assigned to either dispersible (n=447) or crushed tablets (n=452). More than 85% of patients in each treatment group completed the study. 812 children qualified for the modified intention-to-treat analysis (n=403 vs n=409). The PCR-corrected day-28 cure rate was 97·8% (95% CI 96·3-99·2) in the group on dispersible formulation and 98·5% (97·4-99·7) in the group on crushed formulation. The lower bound of the one-sided 97·5% CI was -2·7%. The most common drug-related adverse event was vomiting (n=33 [7%] and n=42 [9%], respectively). No signs of ototoxicity or relevant cardiotoxicity were seen. Interpretation: A six-dose regimen of artemether-lumefantrine with the new dispersible formulation is as efficacious as the currently used crushed tablet in infants and children, and has a similar safety profile. Funding: Novartis Pharma, Basel, Switzerland, and Medicines for Malaria Venture (MMV), Geneva, Switzerland. © 2008 Elsevier Ltd. All rights reserved.
Authors & Co-Authors
Abdulla, Salim Mohammed K.
Tanzania, Ifakara
Ifakara Health Institute
Sagara, Issaka
Mali, Bamako
University of Bamako
Borrmann, Steffen
Kenya, Nairobi
Kenya Medical Research Institute
Germany, Heidelberg
Universität Heidelberg
D'Alessandro, Umberto
Belgium, Antwerpen
Prins Leopold Instituut Voor Tropische Geneeskunde
Benin, Cotonou
Centre de Recherche Entomologique de Cotonou
González, Raquel
Spain, Barcelona
Institut D'investigacions Biomèdiques August pi I Sunyer - Idibaps
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Hamel, Mary J.
Kenya, Nairobi
Kenya Medical Research Institute
Ogutu, Bernhards R.
Kenya, Nairobi
Kenya Medical Research Institute
Mårtensson, Andreas A.
Sweden, Stockholm
Karolinska Universitetssjukhuset
Sweden, Stockholm
Karolinska Institutet
Sweden, Katrineholm
Kullbergska Hospital
Lyimo, John
Tanzania, Ifakara
Ifakara Health Institute
Maïga, Hamidou
Mali, Bamako
University of Bamako
Sasi, Philip Galula
Kenya, Nairobi
Kenya Medical Research Institute
Nahum, Alain
Benin, Cotonou
Centre de Recherche Entomologique de Cotonou
Bassat, Quique
Spain, Barcelona
Institut D'investigacions Biomèdiques August pi I Sunyer - Idibaps
Mozambique, Manhica
Centro de Investigação em Saúde de Manhiça Cism
Juma, Elizabeth A.
Kenya, Nairobi
Kenya Medical Research Institute
Otieno, Lucas
Kenya, Nairobi
Kenya Medical Research Institute
Bjǒrkman, Anders B.
Sweden, Stockholm
Karolinska Universitetssjukhuset
Sweden, Stockholm
Karolinska Institutet
Beck, Hans Peter
Switzerland, Allschwil
Swiss Tropical and Public Health Institute Swiss Tph
Andriano, Kim
Unknown Affiliation
Cousin, Marc
Switzerland, Basel
Novartis International ag
Lefèvre, Gilbert
Switzerland, Basel
Novartis International ag
Ubben, David
Switzerland, Geneva
Medicines for Malaria Venture
Premji, Zulfiqarali G.
Tanzania, Ifakara
Ifakara Health Institute
Statistics
Citations: 137
Authors: 22
Affiliations: 14
Identifiers
Doi:
10.1016/S0140-6736(08)61492-0
ISSN:
01406736
Research Areas
Disability
Infectious Diseases
Maternal And Child Health
Study Locations
Benin
Kenya
Mali
Mozambique
Tanzania