Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

Department of Medical Research, Lower Myanmar

Status: Completed

Conditions: Drug Resistance; Plasmodium Falciparum Malaria

Treatments: Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)

Study type: Observational

Funder types: Other

Identifiers

NCT02792816

KMRL_2016_02

Details and patient eligibility

About

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

Full 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).

Enrollment: 550 patients

Sex: All

Ages: 3 months to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

550 participants in 6 patient groups

Kawthaung Site

Description:

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.

Treatment:

Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)

Myawaddy Site

Description:

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.

Treatment:

Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)

Thanbyuzayat Site

Description:

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.

Treatment:

Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)

Shwegyin Site

Description:

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.

Treatment:

Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)

Magway Site

Description:

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.

Treatment:

Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)

Rakhine Site

Description:

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.

Treatment:

Drug: First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)