Efficacy of Artesunate-amodiaquine (AS-AQ) in Children With Malaria and Severe Acute Malnutrition, Madaoua, Niger 2010
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|ClinicalTrials.gov Identifier: NCT01204411|
Recruitment Status : Withdrawn (The ethics committee did not approve the pharmacokinetic part of the study.)
First Posted : September 17, 2010
Last Update Posted : November 30, 2012
The purpose of the study is to determine whether the artesunate-amodiaquine combination is effective in treating uncomplicated Plasmodium falciparum malaria in children with severe acute malnutrition.
Infection with Plasmodium falciparum malaria remains a significant cause of morbidity and mortality in malnourished children. Malnutrition is known to have a modulating effect on the incidence of malaria infections, its severity and effectiveness of treatments. However, little data exists on antimalarial drug efficacy in malnourished children. Artesunate-amodiaquine combination is the first line treatment used in Médecins Sans Frontières programmes in Niger. The assumption of current efficacy of artesunate-amodiaquine is based on non malnourished children. The aim of this study is to measure the clinical and parasitological efficacy in severely malnourished children.
The study is consistent with the standard WHO protocol for monitoring antimalarial drug efficacy (WHO: Methods for surveillance of antimalarial drug efficacy. Geneva; 2009), except for one inclusion criterion. Severe acute malnutrition is an inclusion criteria, instead of being an exclusion criteria. The study will encompass a pharmacokinetic part that will provide important information on the absorption of the drug.
|Condition or disease||Intervention/treatment||Phase|
|Malaria, Falciparum Malnutrition Child||Drug: Artesunate-amodiaquine fixed-dose combination||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of the Artesunate-amodiaquine Combination for Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Between 6 and 59 Months of Age With Severe Acute Malnutrition in Madaoua, Tahoua Region, Niger|
Drug: Artesunate-amodiaquine fixed-dose combination
- artesunate 25 mg / amodiaquine 67.5 mg: 1 tablet / day for 3 days for children with a weight of 5 kg to less than 9 kg;
- artesunate 50 mg / amodiaquine 135 mg: 1 tablet / day for 3 days for children with a weight of 9 kg to less than 18 kg;
- artesunate 100 mg / amodiaquine 270 mg: 1 tablet / day for 3 days for children with a weight of 18 kg to less than 36 kg;
- To measure the PCR adjusted clinical and parasitological efficacy of the artesunate-amodiaquine combination in children 6-59 months of age with severe malnutrition and uncomplicated P. falciparum malaria over a period of 42 days. [ Time Frame: 42 day follow-up ]
- To assess the incidence of adverse events during the follow-up period [ Time Frame: 42 day follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01204411
|Integrated health centre (CSI)|
|Madaoua, Tahoua, Niger|
|Principal Investigator:||Francesco Grandesso, MSc||Epicentre|