Artemether-Lumefantrine Resistance Monitoring in Children With Uncomplicated Plasmodium Falciparum Malaria in Mali
Sponsor study identifier
Secondary identifiers
observational
154
1 country
1
Study Start
January 1, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 14, 2018
Actual (reported)Study Completion
December 14, 2018
Actual (reported)Background: Malaria is a disease caused by a parasite. People get malaria if they are bitten by an parasite-infected mosquito. A drug called artemether-lumefantrine (AL) can treat malaria. Although iAL has helped make the malaria problem less severe in the African country of Mali, researchers want to find out if malaria parasites are becoming resistant to this drug. Objective: To test for AL-resistant parasites in children with malaria in Mali. Eligibility: AL resistance monitoring study: children aged 2 17 years who live in Kenieroba, Mali, and have malaria. Blood collection substudy: healthy volunteers aged 18 65 years. Design: Volunteers for the substudy will have blood taken up to 6 times a year. Study participants will be screened with 1 finger-prick blood sample. Girls may have a pregnancy test. Baseline visit: Participants will have a physical exam. Their vital signs and temperature will be measured. They will answer questions about their symptoms. They will give a blood sample. Participants will get 6 doses of AL over 3 days. They will take it in tablet form with milk. Some participants will also stay at the clinic for 2 days. They will have a catheter placed in a vein. They will have blood taken frequently. Participants will have follow-up visits for about 1 month. They may have: Physical exam performed Vital signs and temperature measured Symptom questionnaire administered Finger-prick blood sample and/or a regular blood sample taken Pregnancy test given Antimalarial medications other than AL provided.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 14, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2016
Actual (reported)January 1, 2016
Date type not reportedThis date has not been verified as actual or estimated.
January 5, 2016
Actual (reported)December 14, 2018
Actual (reported)December 14, 2018
Actual (reported)Treatment failure up to Day 28. A subject will be defined as a treatment failure if the subject has developed P. falciparum parasitemia detected by thick blood smear (not by PCR) between the time that parasitemia becomes undetectable and Day 28,...
28 days
Malaria Research and Training Center
Bamako, Mali
Lopera-Mesa TM, Doumbia S, Chiang S, Zeituni AE, Konate DS, Doumbouya M, Keita AS, Stepniewska K, Traore K, Diakite SA, Ndiaye D, Sa JM, Anderson JM, Fay MP, Long CA, Diakite M, Fairhurst RM. Plasmodium falciparum clearance rates in response to artesunate in Malian children with malaria: effect of acquired immunity. J Infect Dis. 2013 Jun 1;207(11):1655-63. doi: 10.1093/infdis/jit082. Epub 2013 Feb 28.
Ndour PA, Lopera-Mesa TM, Diakite SA, Chiang S, Mouri O, Roussel C, Jaureguiberry S, Biligui S, Kendjo E, Claessens A, Ciceron L, Mazier D, Thellier M, Diakite M, Fairhurst RM, Buffet PA. Plasmodium falciparum clearance is rapid and pitting independent in immune Malian children treated with artesunate for malaria. J Infect Dis. 2015 Jan 15;211(2):290-7. doi: 10.1093/infdis/jiu427. Epub 2014 Sep 2.
Rick M Fairhurst, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
154 participants (actual enrollment reported by the registry).
First Submitted
January 1, 2016
First Posted
January 5, 2016
Study Start
January 1, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Worldwide Antimalarial Resistance Network (WWARN) AL Dose Impact Study Group. The effect of dose on the antimalarial efficacy of artemether-lumefantrine: a systematic review and pooled analysis of individual patient data. Lancet Infect Dis. 2015 Jun;15(6):692-702. doi: 10.1016/S1473-3099(15)70024-1. Epub 2015 Mar 16.
Petersen JEV, Saelens JW, Freedman E, Turner L, Lavstsen T, Fairhurst RM, Diakite M, Taylor SM. Sickle-trait hemoglobin reduces adhesion to both CD36 and EPCR by Plasmodium falciparum-infected erythrocytes. PLoS Pathog. 2021 Jun 11;17(6):e1009659. doi: 10.1371/journal.ppat.1009659. eCollection 2021 Jun.
Primary Completion
December 14, 2018
Actual (reported)Study Completion
December 14, 2018
Actual (reported)Last Updated
December 17, 2019
Record last verified: 2018-12-14
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