Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

• Register: ClinicalTrials.gov
• Last refreshed on: 20 June 2016
• Main ID: NCT02792816
• Date of registration: 31/05/2016
• Prospective Registration: No
• Primary sponsor: Department of Medical Research, Lower Myanmar
• Public title: Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar
• Scientific title: A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar
• Date of first enrolment: June 2009
• Target sample size: 550
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02792816
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Myanmar

Key inclusion & exclusion 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



Age minimum: 3 Months
Age maximum: 69 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Drug Resistance

Plasmodium Falciparum Malaria

Intervention(s)

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

Primary Outcome(s)

Proportion of adequate clinical and parasitological response (ACPR) [Time Frame: day 28 or day 42 after initial dose of ACT]

Secondary Outcome(s)

Treatment failure rate [Time Frame: anytime within observation period (28/42 days after treatment with one of ACTs)]

Mutant rate [Time Frame: Day-0 samples]

Proportion of the day-3 parasite positivity after ACT by microscopy [Time Frame: 3rd day after initial dose of ACT]

Secondary ID(s)

KMRL_2016_02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Kangwon National University