Day-3 Positive of Parasitaemia Clinical Trial
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
- 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.
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | June 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years and older |
| Eligibility |
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 |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Myanmar | Dr. Myat Phone Kyaw | Yangon |
| Lead Sponsor | Collaborator |
|---|---|
| Myat Htut Nyunt | Kangwon National University |
Myanmar,
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, Ménard 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, Ménard 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. — View 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: — View 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. — View 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. — View Citation
World Health Organization. Global report on antimalarial efficacy and drug resistance: 2000-2010. Geneva, Switzerland: World Health Organization, 2010.
World Health Organization. World Malaria Report 2013. Geneva, Switzerland, 2013.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | day-3 parasite positivity | All of the enrolled patients were monitored with appropriate care up to third day and take the samples on day-3. | 3 days | Yes |
| Secondary | Prevalence of the drug resistance marker | By using the dried blood spots, drug resistance markers were detected by molecular method. | up to day-3 | No |