- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198573
Molecular Assessment of Artemisinin Resistance Markers in Eastern and Western Border Areas of Myanmar
July 22, 2014 updated by: Myat Htut Nyunt
Molecular Assessment of Artemisinin Resistance Markers, K13 Kelch Propeller and Multi-drug Resistant Gene Polymorphism in Eastern and Western Border Areas of Myanmar
- 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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
91
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Yangon, Myanmar, 11191
- Dr. Myat Phone Kyaw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
day-3 parasite positivity
Time Frame: 3 days
|
All of the enrolled patients were monitored with appropriate care up to third day and take the samples on day-3.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of the drug resistance marker
Time Frame: up to day-3
|
By using the dried blood spots, drug resistance markers were detected by molecular method.
|
up to day-3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Myat P Kyaw, PhD, Department of Medical Research, Lower Myanmar
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.
- World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2013
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 22, 2014
First Submitted That Met QC Criteria
July 22, 2014
First Posted (Estimate)
July 23, 2014
Study Record Updates
Last Update Posted (Estimate)
July 23, 2014
Last Update Submitted That Met QC Criteria
July 22, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WHO_3DF_2013_day3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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