Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated falciparum malaria, and chloroquine for vivax malaria in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region, Myanmar

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12611001245987
• Date of registration: 06/12/2011
• Prospective Registration: Yes
• Primary sponsor: Department of Medical Research (Upper Myanmar)
• Public title: Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated falciparum malaria, and chloroquine for vivax malaria in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region, Myanmar
• Scientific title: Efficacy and safety of artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated falciparum malaria, and chloroquine for vivax malaria in Mu-se Township, Northern Shan State and Kalay-Ta-mu townships, Sagaing Region, Myanmar
• Date of first enrolment: 15/12/2011
• Target sample size: 480
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12611001245987.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Phase 4

Countries of recruitment

Myanmar

Contacts

• Name: Dr Marian Warsame

• Name: Dr Khin Lin

Key inclusion & exclusion criteria

Inclusion criteria: *age between 6 years inclusive and above except females aged 12-17 year old inclusive;
*mono-infection with P. falciparum detected by microscopy (parasitaemia of 500-100,000/micro l asexual forms) or P. vivax detected by microscopy (parasitaemia > 250/micro literl asexual forms);
*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; and
*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); and
*a positive pregnancy test or breastfeeding;
*unable to or unwilling to take a pregnancy test or contraceptives.

Age minimum: 6 Years
Age maximum: 60 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Malaria;
Malaria

Infection - Studies of infection and infectious agents

Intervention(s)

One arm propective evaluation with: artemether-lumefantrine and artesunate-mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria and chloroquine for the treatment Plasmodium vivax malaria.

Dose regimen:
Aartemether-lumefantrine tablets (Tablet containing artemether 20 mg/lumefantrine 120 mg) will be given as follows: 6-dose regimen of artemether-lumefantrince twice a day for 3 days according to the following weight bands:5-14 kg body weight (bw): 1 tablet; 15-24 kg body weight (bw): 2 tablets; 25-34 kg body weight (bw): 3 tablets and greater than or equal to 35 kg bw: 4 tablets. All treatment will be orally taken tablets.

Artesunate-mefloquine tablets co-administered as artesunate 4mg/kg/day for three days + mefloquine 25 mg base/kg (split dose as 15mg/kg on day 0 followed by 10mg/kg on day 1).

Chloroquine phophate tablets (tablet contains 150 mg base): 25 mg/kg body weight ober 3 consecutive days (10 mg/kg body weight on day 0, 10 mg/kg body weight (bw) on day 1 and 5 mg/kg body weight (bw) on day 2).

All treatment will be orally taken tablets.

Primary Outcome(s)

% of artemether-lumefantrine, artesunate-mefloquine and chloroquine treatment failures (early treatment failure+late clinical failure+late parasitological failure). Enrolled patients will be assessed for parasitological (using microscopy) and clinical responses during the 28 days follow-up and treatmnt outcomes will be classified according to the latest World Health Organization (WHO) protocol (http://www.who.int/malaria/publications/atoz/9789241597531/en/index.html).[At 28 day following artemether-lumefantrine or chloroquine treatment or at 42 day following artesunate-mefloquine treatment.]

% of adverse events in the artemether-lumefantrine, artesunate-mefloquine and chloroquine treated groups. All patients will be asked routinely about previous symptoms and about symptoms that have emerged since the previous follow-up visit. All adverse events will be recorded on the case report form.[At 28 day following artemether-lumefantrine or chloroquine treatment or at 42 day following artesunate-mefloquine treatment.]

Secondary Outcome(s)

Nil[Nil]

Secondary ID(s)

Nil

Source(s) of Monetary Support

Department of Medical Research (Upper Myanmar)

Ethics review

Status: Approved
Approval date:
Contact:

Ethical Review Committee, World Health Organization

Status: Approved
Approval date:
Contact:

Etical Committee on Medical Research Involving Human Subjects