Clinical trial NCT02198573: Molecular Assessment of Artemisinin Resistance Markers in Eastern and Western Border Areas of Myanmar
Official title: Molecular Assessment of Artemisinin Resistance Markers, K13 Kelch Propeller and Multi-drug Resistant Gene Polymorphism in Eastern and Western Border Areas of Myanmar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Day-3 Positive of Parasitaemia
Prevalence of Drug Resistance Gene Mutation
Keywords: malaria
K13
pfmrp1
Myanmar
Lead sponsor: Department of Medical Research, Lower Myanmar
Sponsor class: OTHER
Collaborators: name: Kangwon National University
First posted: 2014-07-23
Enrollment: 91
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All of the malaria suspected cases were invited to participated in this study from Myanmar-Thailand border and Myanmar-Bangladesh border.

Brief summary: * Artemisinin resistance have been documented in Myanmar and Myanmar artemisinin resistance containment measures have been launched since 2009-2010.
* It is important to monitor the spread and magnitude of artemisinin resistant malaria in Myanmar.
* So, day-3 surveillance study have been conducted.
* Recently artemisinin resistant molecular marker, K13 have been identified and it was used as a tool in this study.


Eligibility criteria: Inclusion Criteria:

* confirmed uncomplicated falciparum malaria patients.
* age \>2 years
* box sex
* given informed consent

Exclusion Criteria:

* severe malaria
* did not give informed consent
* others diseases

Primary outcomes:
measure: day-3 parasite positivity
timeFrame: 3 days
Secondary outcomes:
measure: Prevalence of the drug resistance marker
timeFrame: up to day-3
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Dr. Myat Phone Kyaw
Study officials:
affiliation: Department of Medical Research, Lower Myanmar
name: Myat P Kyaw, PhD
role: STUDY_DIRECTOR
References:
citation: World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.
citation: World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.
citation: Stepniewska K, Ashley E, Lee SJ, Anstey N, Barnes KI, Binh TQ, D'Alessandro U, Day NP, de Vries PJ, Dorsey G, Guthmann JP, Mayxay M, Newton PN, Olliaro P, Osorio L, Price RN, Rowland M, Smithuis F, Taylor WR, Nosten F, White NJ. In vivo parasitological measures of artemisinin susceptibility. J Infect Dis. 2010 Feb 15;201(4):570-9. doi: 10.1086/650301.
citation: Ariey F, Witkowski B, Amaratunga C, Beghain J, Langlois AC, Khim N, Kim S, Duru V, Bouchier C, Ma L, Lim P, Leang R, Duong S, Sreng S, Suon S, Chuor CM, Bout DM, Menard S, Rogers WO, Genton B, Fandeur T, Miotto O, Ringwald P, Le Bras J, Berry A, Barale JC, Fairhurst RM, Benoit-Vical F, Mercereau-Puijalon O, Menard D. A molecular marker of artemisinin-resistant Plasmodium falciparum malaria. Nature. 2014 Jan 2;505(7481):50-5. doi: 10.1038/nature12876. Epub 2013 Dec 18.
citation: Singh B, Bobogare A, Cox-Singh J, Snounou G, Abdullah MS, Rahman HA. A genus- and species-specific nested polymerase chain reaction malaria detection assay for epidemiologic studies. Am J Trop Med Hyg. 1999 Apr;60(4):687-92. doi: 10.4269/ajtmh.1999.60.687.
citation: Kyaw MP, Nyunt MH, Chit K, Aye MM, Aye KH, Aye MM, Lindegardh N, Tarning J, Imwong M, Jacob CG, Rasmussen C, Perin J, Ringwald P, Nyunt MM. Reduced susceptibility of Plasmodium falciparum to artesunate in southern Myanmar. PLoS One. 2013;8(3):e57689. doi: 10.1371/journal.pone.0057689. Epub 2013 Mar 8.