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Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

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ClinicalTrials.gov Identifier: NCT02792816
Recruitment Status : Completed
First Posted : June 8, 2016
Last Update Posted : June 8, 2016
Sponsor:
Collaborator:
Kangwon National University
Information provided by (Responsible Party):
Myat Htut Nyunt, Department of Medical Research, Lower Myanmar

Brief Summary:
Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis

Condition or disease Intervention/treatment
Drug Resistance Plasmodium Falciparum Malaria Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)

Detailed Description:
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).

Study Type : Observational
Actual Enrollment : 550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar
Study Start Date : June 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Group/Cohort Intervention/treatment
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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.
Drug: 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.




Primary Outcome Measures :
  1. Proportion of adequate clinical and parasitological response (ACPR) [ Time Frame: day 28 or day 42 after initial dose of ACT ]
    For artesunate-mefloquine or dihydroartemisinin-piperaquine, 42 days follow-ups and for artemether-lumefrantrine combinations, 28 days followe-ups


Secondary Outcome Measures :
  1. Proportion of the day-3 parasite positivity after ACT by microscopy [ Time Frame: 3rd day after initial dose of ACT ]
    72 hr after ACT is one of the indicator for delayed clearance of parasitaemia in falciparum malaria

  2. Treatment failure rate [ Time Frame: anytime within observation period (28/42 days after treatment with one of ACTs) ]
    Early Treatment Failure (ETF), Late Clinical Failure (LCF), Late Parasitological Failure (LPF) based on the WHO standard protocol and definitions

  3. Mutant rate [ Time Frame: Day-0 samples ]
    Day-0 samples were used to amplify the artemisinin resistance molecular markers to know the mutant rate in each study sites


Biospecimen Retention:   Samples With DNA
Finger prick blood samples were taken onto filter paper and Keep dry until DNA extraction.


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Ages Eligible for Study:   3 Months to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study populations were selected purposely based on the previous evidence of the drug resistance in Myanmar
Criteria

Inclusion Criteria:

  • Plasmodium falciparum mono infection by microscopy
  • 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:

  • Presence of signs of severe falciparum malaria according to the definitions of World Health Organisation (WHO)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02792816


Locations
Myanmar
Dr. Myat Phone Kyaw
Yangon, Myanmar, 11191
Sponsors and Collaborators
Department of Medical Research, Lower Myanmar
Kangwon National University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Myat Htut Nyunt, Research Scientist, Department of Medical Research, Lower Myanmar
ClinicalTrials.gov Identifier: NCT02792816     History of Changes
Other Study ID Numbers: KMRL_2016_02
First Posted: June 8, 2016    Key Record Dates
Last Update Posted: June 8, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We may share the data on request after publication.

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Artemether
Piperaquine
Dihydroartemisinin
Mefloquine
Antimalarials
Artemisinins
Artemisinine
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics