Clinical trial NCT02792816: Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar
Official title: A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug Resistance
Plasmodium Falciparum Malaria
Lead sponsor: Department of Medical Research, Lower Myanmar
Sponsor class: OTHER
Collaborators: name: Kangwon National University
First posted: 2016-06-08
Enrollment: 550
Sex: ALL
Minimum age (years): 3
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study populations were selected purposely based on the previous evidence of the drug resistance in Myanmar

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

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).

Eligibility 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

Primary outcomes:
measure: Proportion of adequate clinical and parasitological response (ACPR)
timeFrame: day 28 or day 42 after initial dose of ACT
Secondary outcomes:
measure: Proportion of the day-3 parasite positivity after ACT by microscopy
timeFrame: 3rd day after initial dose of ACT
measure: Treatment failure rate
timeFrame: anytime within observation period (28/42 days after treatment with one of ACTs)
measure: Mutant rate
timeFrame: Day-0 samples
Other outcomes:
Locations:
city: Yangon
country: Myanmar
facility: Dr. Myat Phone Kyaw
Study officials:
References:
citation: 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.