The Impact of Artemether-Lumefantrine on Genes Associated With Antimalarial Resistance
NCT ID: NCT00440752
Last Updated: 2008-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
100 participants
OBSERVATIONAL
2006-10-31
2006-12-31
Brief Summary
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Detailed Description
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However, there has been no report of the impact of these combinations on drug resistance markers in Sudan. Data from other African countries has shown that AL selects for certain alleles in the pfmdr-1 gene (Sisowath et al., 2005, Dokomajilar et al., 2006; Humphreys et al., 2007), but the impact on the prevalence of different pfcrt and pfmdr-1alleles remains unclear. It is essential to monitor ACT efficacy in addition to identify molecular markers that are associated with response to different drugs to facilitate epidemiological surveys for evidence based decision making. Recent work in The Gambia suggests that transmission-related endpoints, such as emergence of gametocytes after treatment, may be better indicators of emerging drug resistance (Hallett et al., 2006).
The aim of the proposed study is to examine the impact of treatment with artemether-lumefantrine (AL) on alleles of pfcrt and pfmdr-1 in P. falciparum isolates in an area of marked seasonal transmission in eastern Sudan. Most studies of resistance markers measure marker prevalence by DNA amplification, but we will also investigate gene expression using quantitative amplification of mRNA encoding pfcrt and pfmdr-1. The impact of genotype and gene expression levels on treatment outcome, and on the emergence and density of peripheral gametocytes will be examined.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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AL
Cohort of study participants receiving treatment with artemether-lumefantrine
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Initial parasite density of 1000 to 100,000 asexual parasites/µl.
* Absence of general danger signs or other signs of severe and complicated falciparum malaria according to WHO definitions.
* Informed consent provided by patient or parent/guardian.
Exclusion Criteria
* Infection with mixed Plasmodium sp.
* Signs of severe malaria or any danger signs
* Refusal to provide consent
2 Years
ALL
Yes
Sponsors
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London School of Hygiene and Tropical Medicine
OTHER
World Health Organization
OTHER
International Atomic Energy Agency
OTHER_GOV
Tropical Medicine Research Institute
OTHER
Principal Investigators
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Colin Sutherland, PhD.
Role: PRINCIPAL_INVESTIGATOR
London School of Hygiene and Tropical Medicine
Badria B El-Sayed, PhD
Role: STUDY_CHAIR
Tropical Medicine Research Institute
Locations
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Tropical Medicine Research Institute
Khartoum, Khartoum State, Sudan
Countries
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References
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Dokomajilar C, Nsobya SL, Greenhouse B, Rosenthal PJ, Dorsey G. Selection of Plasmodium falciparum pfmdr1 alleles following therapy with artemether-lumefantrine in an area of Uganda where malaria is highly endemic. Antimicrob Agents Chemother. 2006 May;50(5):1893-5. doi: 10.1128/AAC.50.5.1893-1895.2006.
Humphreys GS, Merinopoulos I, Ahmed J, Whitty CJ, Mutabingwa TK, Sutherland CJ, Hallett RL. Amodiaquine and artemether-lumefantrine select distinct alleles of the Plasmodium falciparum mdr1 gene in Tanzanian children treated for uncomplicated malaria. Antimicrob Agents Chemother. 2007 Mar;51(3):991-7. doi: 10.1128/AAC.00875-06. Epub 2006 Dec 28.
Sisowath C, Stromberg J, Martensson A, Msellem M, Obondo C, Bjorkman A, Gil JP. In vivo selection of Plasmodium falciparum pfmdr1 86N coding alleles by artemether-lumefantrine (Coartem). J Infect Dis. 2005 Mar 15;191(6):1014-7. doi: 10.1086/427997. Epub 2005 Feb 8.
Other Identifiers
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AL Oct-Dec/06-07
Identifier Type: -
Identifier Source: org_study_id