Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

NCT02792816 | Completed DMC

• 1 other identifier: KMRL_2016_02
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Resistance; Plasmodium Falciparum Malaria

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Proportion of the day-3 parasite positivity after ACT by microscopy

  3rd day after initial dose of ACT

• Treatment failure rate

  anytime within observation period (28/42 days after treatment with one of ACTs)

• Mutant rate

  Day-0 samples

Study Arms (6)

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)

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)

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)

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)

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)

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)

Interventions

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.

Kawthaung Site; Magway Site; Myawaddy Site; Rakhine Site; Shwegyin Site; Thanbyuzayat Site

Eligibility Criteria

• Age: 3 Months - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study populations were selected purposely based on the previous evidence of the drug resistance in Myanmar

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Research, Lower Myanmar: lead
• Kangwon National University: collaborator

Study Sites (1)

Dr. Myat Phone Kyaw

Yangon, Yangon, 11191, Burma

Location

Related Publications (1)

• 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.

  PMID: 28806957 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Finger prick blood samples were taken onto filter paper and Keep dry until DNA extraction.

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: June 8, 2016
• Study Start: June 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2016
• Last Updated: June 8, 2016

Record last verified: 2016-06

Locations

BU (1)