Molecular Surveillance of Artemisinin Resistance Malaria in Myanmar

Plasmodium Falciparum Malaria Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792816
• Other study ID #: KMRL_2016_02
• Status: Completed
• Phase: N/A
• First received: May 31, 2016
• Last updated: June 7, 2016
• Start date: June 2009
• Est. completion date: May 2016

Study information

• Verified date: June 2016
• Source: Department of Medical Research, Lower Myanmar
• Contact: n/a
• Is FDA regulated: No
• Health authority: Myanmar: Ethical Review Committee
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Resistance
• Malaria
• Malaria, Falciparum
• Plasmodium Falciparum Malaria

Intervention

Drug:
• First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)
Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.

Locations

Country	Name	City	State
Myanmar	Dr. Myat Phone Kyaw	Yangon

Sponsors (2)

Lead Sponsor	Collaborator
Department of Medical Research, Lower Myanmar	Kangwon National University

Country where clinical trial is conducted

Myanmar, 

Outcome

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

External Links

•   WHO standardized protocol for surveillance of antimalarial