Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Ta Beik Kyin Township, Mandalay Region and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria in Ta-mu township, Sagaing Region

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000216617
• Date of registration: 28/02/2014
• Prospective Registration: No
• Primary sponsor: Department of Medical Research (Upper Myanmar)
• Public title: Efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria, and chloroquine for Plasmodium vivax in Ta Beik Kyin Township, Mandalay Region and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria in Ta-mu township, Sagaing Region
• Scientific title: A study evaluating the efficacy and safety of artemether-lumefantrine and dihydroartemisinin-piperaquine phosphate for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for plasmodium vivax malaria in in Ta Beik Kyin Township, Mandalay Region and Ta-mu township, Sagaing Region, Myanmar
• Date of first enrolment: 10/01/2014
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12614000216617.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Phase 3 / Phase 4

Countries of recruitment

Myanmar

Contacts

• Name: Dr Moe Kyaw Myint

• Name: Dr Khin Lin

Key inclusion & exclusion criteria

Inclusion criteria: Criteria are. ge between 6 years inclusive and above; mono-infection with plasmodium falciparum detected by microscopy (parasitaemia of 500-100,000/microlitre asexual forms) or plasmodium vivax detected by microscopy (parasitaemia great than 250/microlitre asexual forms); presence of axillary equal to or great than 37.5 degrees celcius or history of fever during the past 24 h; 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; and informed consent from the patient or from a parent or guardian in the case of children.

Exclusion criteria: presence signs of severe falciparum malaria according to the definitions of 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 less than 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, HIV/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 for falciparum malaria; and unable to or unwilling to take a pregnancy test or contraceptives.


Age minimum: 6 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Malaria;
Malaria

Intervention(s)

For Plasmodium falciparum:
The first 80 patients will receive Artemether-Lumefantrine (in a fixed combination of 20 mg of artemether and 120 mg of lumefantrine in a tablet) will be administered orally in a twice daily dose for three days, as follows: One tablet to those weighing 5-14kg; two tablets to children with 15-24 kg and three tablets to children weighing 25-35 kg. Four tablets to those over 35kg. The full course of treatment for all study patients consists of 6-doses given twice daily.

The next 80 patients will be administered dihydroartemisinin-piperaquine. A fixed dose of 40 mg dihydroartemisinin and 320 mg piperaquine phosphate) will be administered orally as a weight per dose regimen of 2.25 and 18 mg/kg per dose of dihydroartemisinin and piperaquine phosphate. The medicine will be given a daily dose over three days.

For plasmodium vivax: Chloroquine phosphate 150 mg base per tablet will be given a total dose of 25 mg per kg. body weight as: 10 mg per kg body weight for days 1 and 2 while 5 mg per kg body weight on day 3.

All drug administration is supervised over the period of three days.

Primary Outcome(s)

The study end-point is the classification assigned to a patient. Valid study end-points include: treatment failure, completion of the follow-up period without treatment failure, loss to follow-up, withdrawal from study, and protocol violation. At all times, the well-being of the patient will take priority over his or her continuation in the study.

Early treatment failure: danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia;parasitaemia on day 2 higher than on day 0, irrespective of axillary temperature; parasitaemia on day 3 with axillary temperature equal to 37.5 degrees celsius; parasitaemia on day 3 equals 25percent of count on day 0.
Late treatment failure:
1 Late clinical failure - danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 28 (day 42) in patients who did not previously meet any of the criteria of early treatment failure; or presence of parasitaemia on any day between day 4 and day 28 with axillary temperature equal to or great than 37.5 degrees celsius ( or history of fever) in patients who did not previously meet any of the criteria of early treatment failure

Late parasitological failure - presence of parasitaemia on any day between day 7 and day 28 with axillary temperature great than 37.5 degrees celsius in in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure

Adequate clinical and parasitological response - absence of parasitaemia on day 28, irrespective of axillary temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure
[A standard physical examination will be performed at baseline (day 0 before dosing) and on days 1, 2, 3, 7, 14, 21, 28, 35 and 42 days. A complete medical history, demographic information and contact details will be taken at baseline.]

Secondary Outcome(s)

nil[nil]

Secondary ID(s)

Nil

Source(s) of Monetary Support

World Health Organization

Ethics review

Status: Approved
Approval date:
Contact:

Ethical Review Committee, World Health Organization

Status: Approved
Approval date:
Contact:

Republic of the Union of Myanmar, Ministry of Health