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Artemisinin-resistant Plasmodium Falciparum Malaria in Cambodia
Sponsor study identifier
Secondary identifiers
observational
561
1 country
1
Study Start
June 26, 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
April 6, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Background: \- Artemisinin-based combination therapies (ACTs) are the first-line treatments for malaria. ACTs are highly effective, but malaria caused by the Plasmodium falciparum parasite is becoming resistant to some ACTs. ACT-resistant malaria has shown up in some parts of Cambodia, but not yet in other parts of the country. This has been shown by treating patients with ACTs, checking the amount of parasites in the patient s blood every 6 hours, and calculating the rate of parasite clearance. The parasite clearance rate in response to ACTs is getting slower in western Cambodia and may be the first sign of ACT resistance. Researchers want to study how effective ACTs are in different regions of Cambodia. This study will look at the extent of ACT resistance and how widespread ACT-resistant malaria has become. Objectives: \- To compare the prevalence of ACT-resistant malaria in western, northern and eastern Cambodia. Eligibility: \- Individuals between 2 and 65 years of age who have uncomplicated Plasmodium falciparum malaria and have not taken any antimalarial drugs for their symptoms in the previous 7 days. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 6, 2016
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 26, 2012
Date type not reportedThis date has not been verified as actual or estimated.
November 27, 2012
Actual (reported)November 29, 2012
Actual (reported)April 6, 2016
Date type not reportedThis date has not been verified as actual or estimated.
National Center for Parasitology, Entomology, and Malaria Controk, Ministry of H
Phnom Penh, Cambodia
Dondorp AM, Nosten F, Yi P, Das D, Phyo AP, Tarning J, Lwin KM, Ariey F, Hanpithakpong W, Lee SJ, Ringwald P, Silamut K, Imwong M, Chotivanich K, Lim P, Herdman T, An SS, Yeung S, Singhasivanon P, Day NP, Lindegardh N, Socheat D, White NJ. Artemisinin resistance in Plasmodium falciparum malaria. N Engl J Med. 2009 Jul 30;361(5):455-67. doi: 10.1056/NEJMoa0808859.
Phyo AP, Nkhoma S, Stepniewska K, Ashley EA, Nair S, McGready R, ler Moo C, Al-Saai S, Dondorp AM, Lwin KM, Singhasivanon P, Day NP, White NJ, Anderson TJ, Nosten F. Emergence of artemisinin-resistant malaria on the western border of Thailand: a longitudinal study. Lancet. 2012 May 26;379(9830):1960-6. doi: 10.1016/S0140-6736(12)60484-X. Epub 2012 Apr 5.
Rick M Fairhurst, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
561 participants (actual enrollment reported by the registry).
First Submitted
November 27, 2012
First Posted
November 29, 2012
Study Start
June 26, 2012
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
White NJ. The parasite clearance curve. Malar J. 2011 Sep 22;10:278. doi: 10.1186/1475-2875-10-278.
Amaratunga C, Lim P, Suon S, Sreng S, Mao S, Sopha C, Sam B, Dek D, Try V, Amato R, Blessborn D, Song L, Tullo GS, Fay MP, Anderson JM, Tarning J, Fairhurst RM. Dihydroartemisinin-piperaquine resistance in Plasmodium falciparum malaria in Cambodia: a multisite prospective cohort study. Lancet Infect Dis. 2016 Mar;16(3):357-65. doi: 10.1016/S1473-3099(15)00487-9. Epub 2016 Jan 8.
Witkowski B, Amaratunga C, Khim N, Sreng S, Chim P, Kim S, Lim P, Mao S, Sopha C, Sam B, Anderson JM, Duong S, Chuor CM, Taylor WR, Suon S, Mercereau-Puijalon O, Fairhurst RM, Menard D. Novel phenotypic assays for the detection of artemisinin-resistant Plasmodium falciparum malaria in Cambodia: in-vitro and ex-vivo drug-response studies. Lancet Infect Dis. 2013 Dec;13(12):1043-9. doi: 10.1016/S1473-3099(13)70252-4. Epub 2013 Sep 11.
Study Completion
April 6, 2016
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
June 1, 2018
Record last verified: 2016-04-06
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Source: ClinicalTrials.gov.
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