Efficacy and safety of artemeter-lumefantrine in the treatment of uncomplicated malaria-causing Plasmodium falciparum infections in Botswana

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000276257
• Date of registration: 15/05/2009
• Prospective Registration: No
• Primary sponsor: Ministry of Health
• Public title: Efficacy and safety of artemeter-lumefantrine in the treatment of uncomplicated malaria-causing Plasmodium falciparum infections in Botswana
• Scientific title: Efficacy and safety of artemeter-lumefantrine in the treatment of uncomplicated malaria-causing Plasmodium falciparum infections in Botswana
• Date of first enrolment: 01/04/2009
• Target sample size: 261
• Recruitment status: Stopped early
• URL: https://anzctr.org.au/ACTRN12609000276257.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;
• Phase: Phase 4

Countries of recruitment

Botswana

Contacts

• Name: Dr Dr Ringwald Pascal

• Name: Dr Dr Ringwald Pascal

Key inclusion & exclusion criteria

Inclusion criteria: age six months and above;
mono-infection with Plasmodium falciparum detected by microscopy;
parasitaemia of 500–200 000 asexual forms /microl blood;
presence of axillary temperature = 37.5 degre C and/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 of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of World Health Organization;
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 < 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 immunodeficiency virus/acquired immunodeficiency syndrome);
regular medication, which may interfere with antimalarial pharmacokinetics;
history of hypersensitivity reactions or contraindications to any of the drug(s) being tested or used as alternative treatment(s); and
a positive pregnancy test or breastfeeding.

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

Health Condition(s) or Problem(s) studied

Antimalarial medicine efficacy;
Antimalarial medicine efficacy

Infection - Other infectious diseases

Intervention(s)

artemether-lumefantrine, 20 mg artemether and 120 mg lumefantrine per tablet, malaria treatment, oral treatment 1 tablet for 5-14 kg, 2 tablets for 15-24 kg, 3 tablets 25-34, 4 tablets over 35 kg twice a day over 3 days

Primary Outcome(s)

Clinical efficacy monitored by health care professionals by clinical eximaniation and temperature measurement and parasitological efficacy monitored by labortaory techniciansby thick blood smear[28 days post-testing initial treatment]

Secondary Outcome(s)

Prevalence of side effects assessed by questionnaire[28 days post-testing initial treatment]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

Ministry of Health

Ethics review

Status: Approved
Approval date:
Contact:

Ministry of Health