Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar
NCT ID: NCT02792816
Last Updated: 2016-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
550 participants
OBSERVATIONAL
2009-06-30
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
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.
First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
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.
First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
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.
First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
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.
First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
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.
First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
Interventions
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First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
Eligibility Criteria
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Inclusion Criteria
* Presence of axillary equal to or more than 37.5 degrees centigrade or history of fever during the past 24 hours
* Ability to swallow oral medication
* Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule
* Informed consent from the patient or from a parent or guardian in the case of children
Exclusion Criteria
* Mixed or mono-infection with another Plasmodium species detected by microscopy
* Presence of severe malnutrition (defined as a child whose growth standard is below 3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference below 110 mm)
* Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, Human Immune Deficiency Virus (HIV)/Acquired Immune Deficiency Syndrom (AIDS)
* Regular medication, which may interfere with antimalarial pharmacokinetics
* History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s)
* A positive pregnancy test or breastfeeding
* Unable to or unwilling to take a pregnancy test or contraceptives
3 Months
69 Years
ALL
No
Sponsors
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Kangwon National University
OTHER
Department of Medical Research, Lower Myanmar
OTHER
Responsible Party
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Myat Htut Nyunt
Research Scientist
Locations
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Dr. Myat Phone Kyaw
Yangon, Yangon, Burma
Countries
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References
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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.
Other Identifiers
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KMRL_2016_02
Identifier Type: -
Identifier Source: org_study_id
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