Plasmodium Falciparum Malaria Clinical Trial
Official title:
A Multi-site Cohort Observational Study for Molecular Assessment of Artemisinin Resistance Falciparum Malaria in Myanmar
Efficacy and safety of the artemisinin combination therapy (ACT) in uncomplicated falciparum malaria patients in Myanmar and artemisinin molecular markers analysis
Status | Completed |
Enrollment | 550 |
Est. completion date | May 2016 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 3 Months to 69 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Myanmar | Dr. Myat Phone Kyaw | Yangon |
Lead Sponsor | Collaborator |
---|---|
Department of Medical Research, Lower Myanmar | Kangwon National University |
Myanmar,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Proportion of the day-3 parasite positivity after ACT by microscopy | 72 hr after ACT is one of the indicator for delayed clearance of parasitaemia in falciparum malaria | 3rd day after initial dose of ACT | Yes |
Secondary | Treatment failure rate | Early Treatment Failure (ETF), Late Clinical Failure (LCF), Late Parasitological Failure (LPF) based on the WHO standard protocol and definitions | anytime within observation period (28/42 days after treatment with one of ACTs) | Yes |
Secondary | Mutant rate | Day-0 samples were used to amplify the artemisinin resistance molecular markers to know the mutant rate in each study sites | Day-0 samples | No |
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