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Completed

NCT Number: NCT02792816

Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

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

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Key information

Age range

3 month–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. Myat Phone Kyaw

Yangon, 11191, Burma

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Department of Medical Research, Lower Myanmar

Other

Collaborators

  • Kangwon National University

Registry information

Official study title

A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar

Important dates

Study start
2009
Primary completion
2013
Study completion
2016
First posted
Jun 8, 2016
Registry last updated
Jun 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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