Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in the provinces of Zivie/Atlantic, Kouande/Atacora and Zakpota /Zou in the Republic of Benin

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12613001258741
• Date of registration: 18/11/2013
• Prospective Registration: Yes
• Primary sponsor: Ministere de la Sante Benin
• Public title: Efficacy and safety of artemether-lumefantrine for the treatment of uncomplicated falciparum malaria in the provinces of Zivie/Atlantic, Kouande/Atacora and Zakpota /Zou in the Republic of Benin
• Scientific title: Therapeutic efficacy and safety study of fixed combination of artemether-lumefantrine for the treatment of children with uncomplicated falciparum malaria in the provinces of Zivie/Atlantic, Kouande/Atacora and Zakpota /Zou in the Republic of Benin
• Date of first enrolment: 22/11/2013
• Target sample size: 180
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12613001258741.aspx
• Study type: Observational
• Study design: Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
• Phase: Not Applicable

Countries of recruitment

Benin

Contacts

• Name: Dr Yves Eric Donan Denon

• Name: Dr Yves Eric Donan Denon

Key inclusion & exclusion criteria

Inclusion criteria: Age between 6 months and 12 years
Minimum body weight of 5kg
Mono-infection with plasmodium falciparum confirmed by microscopy
Parasitemia between 1000-200000 asexual forms parasites per microliter
Axillary temperature equal or greater than 37.5 degrees Celsius or history of fever in the past 24 hours
Able to swallow oral medication
Capable and willing to follow protocol requirement, including schedule of assessments
Written consent from parent/guardian


Exclusion criteria: Presence of signs in children aged under 5 years, or signs of severe falciparum malaria according to WHO definition
Mixed or mono infection with another Plasmodium species detected by microscopy
Presence of severe malnutrition (defined as a child whose growth standard is below minus 3z score, has symmetrical oedema involving at least the feet, or has mid-upper arm circumference less than 110 mm
Presence of febrile conditions due to diseases other than malaria (measles, acute lower respiratory tract infection, severe diarrhea with dehydration), or other known underlying chronic diseases (cardiac, renal and hepatic diseases, HIV/AIDS)
Regular medications, which may interfere with the antimalarial pharmacokinetics
History of hypersensitivity reaction or contraindications to any of the medicine(s) being tested or used as alternative treatments

Age minimum: 6 Months
Age maximum: 12 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Uncomplicated falciparum malaria;
Uncomplicated falciparum malaria

Intervention(s)

This is a an open label single arm surveillance study to confirm the efficacy and safety of the first-line antimalarial treatment, artemether-lumefantrine, for the treatment of uncomplicated falciparum malaria in children aged between 6 months a 12 years. All eligible patients will be enrolled on day 0 and received artemether-lumefantrine as fixed-combination tablet (20 mg artemether and 120 mg lumefantrine) twice daily for 3 consecutive days. The number of tablets to be administered for each dose ( morning and evening) is based on body weight according to standard treatment (5-14 kg, 1 tb; 15-24 kg, 2 tb; 25-34 kg, 3 tb; over 35 kg 4 tb). Each dose will be administered under the supervision of a qualified study staff member. Clinical and parasitological examinations will be conducted at each of the scheduled follow-up visit on days 1,2,3,7,14,21, and 28 or any other day if symptoms re-occurred.

Primary Outcome(s)

Proportion of patients with adequate clinical and parasitological response adjusted by PCR (polymerase chain reaction)[Day 28]

Secondary Outcome(s)

Incidence and nature of adverse events. Possible adverse events are those known to occur with antimalarials and include, headache, body ache, nausea, vomiting, abdominal discomfort, liver enzyme elelevation, and dizziness[Day 28]

In vitro susceptibility testing of Plasmodium isolates to artemether-lumefantrine[Day 0]

Hematocrit[Baseline and Day 28]

Secondary ID(s)

None

Source(s) of Monetary Support

Ministere de la Sante Benin Programme National de Lutte contre le Paludisme (PNLP)

World Health Organization

Ethics review

Status: Approved
Approval date:
Contact:

World Health Organisation Ethics Review Committee