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| Name | Class |
|---|---|
| Kangwon National University | OTHER |
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Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis
The investigators assessed the efficacy and safety of the ACT in uncomplicated falciparum malaria in different sentinel sites in Myanmar. The recruited patients were follow-up until day 28 or day-42 based on the ACTs. Day-0 samples were analysed for artemisinin molecular markers, (K13 kelch propeller, Pfmdr2, Pffd and Pfarps10).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kawthaung Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Kawthaung is one of the sentinel site and located at the Southern Myanmar. |
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| Myawaddy Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Myawaddy is one of the sentinel site and located at the northern part of the Southern Myanmar. |
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| Thanbyuzayat Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Thanbyuzayat is one of the sentinel site and located at the northern part of the Southern Myanmar. |
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| Shwegyin Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Shwegyin is one of the sentinel site and located at the southern part of the central Myanmar. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine) | Drug | Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of adequate clinical and parasitological response (ACPR) | For artesunate-mefloquine or dihydroartemisinin-piperaquine, 42 days follow-ups and for artemether-lumefrantrine combinations, 28 days followe-ups | day 28 or day 42 after initial dose of ACT |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of the day-3 parasite positivity after ACT by microscopy | 72 hr after ACT is one of the indicator for delayed clearance of parasitaemia in falciparum malaria | 3rd day after initial dose of ACT |
| Treatment failure rate |
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Inclusion Criteria:
Exclusion Criteria:
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Study populations were selected purposely based on the previous evidence of the drug resistance in Myanmar
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Myat Phone Kyaw | Yangon | Yangon | 11191 | Burma |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28806957 | Derived | Nyunt MH, Soe MT, Myint HW, Oo HW, Aye MM, Han SS, Zaw NN, Cho C, Aung PZ, Kyaw KT, Aye TT, San NA, Ortega L, Thimasarn K, Bustos MDG, Galit S, Hoque MR, Ringwald P, Han ET, Kyaw MP. Clinical and molecular surveillance of artemisinin resistant falciparum malaria in Myanmar (2009-2013). Malar J. 2017 Aug 14;16(1):333. doi: 10.1186/s12936-017-1983-9. |
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We may share the data on request after publication.
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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Finger prick blood samples were taken onto filter paper and Keep dry until DNA extraction.
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| Magway Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Magway is one of the sentinel site and located at the middle part of the central Myanmar. |
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| Rakhine Site | The efficacy and safety of the ACT in different sentinel sites will be assessed. The administrated anti-malarial were same and all will be administrated under direct observation. The dosage will be calculated by weight of the patients. Rakhine is one of the sentinel site and located at the western Myanmar. |
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Early Treatment Failure (ETF), Late Clinical Failure (LCF), Late Parasitological Failure (LPF) based on the WHO standard protocol and definitions
| anytime within observation period (28/42 days after treatment with one of ACTs) |
| Mutant rate | Day-0 samples were used to amplify the artemisinin resistance molecular markers to know the mutant rate in each study sites | Day-0 samples |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |