Treatment of Uncomplicated Childhood Malaria in Tanzania by Artemether+Lumefantrine - Efficacy and Genotyping

Study Overview
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Brief Summary
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The purpose of this explorative clinical trial is to study parasite population dynamics, diversity and clearance kinetics of Plasmodium falciparum as well as determination of the molecular mechanisms associated with drug resistance during the early phase of artemether-lumefantrine treatment when the drug intake is either accompanied with or without intake of fatty food. The hypothesis is that intake of fatty food together with artemether-lumefantrine will enhance parasite clearance and thereby decrease the risk of early selection of genetic markers related to drug resistance. The study population is children aged 1-10 years with uncomplicated malaria in Bagamoyo District, Tanzania. Enrolled children will be randomly allocated to either intake of a fatty meal or not together with the study drug. Artemether-lumefantrine will be given twice daily for 3 days in standard doses according to bodyweight. Study participants will be admitted during the study period (3 days)to allow close supervision and detailed blood sampling.

Official Title
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Treatment of Uncomplicated Childhood Malaria by an Artemisinin Derivative in Combination With Lumefantrine. Efficacy, Safety and Genotyping.

Conditions
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Malaria

Intervention / Treatment
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* Drug: artemether-lumefantrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 1-10 years Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL No general danger signs or severe malaria present Haemoglobin ≥70 g/L History of fever within 24 hours OR axillary temperature ≥ 37.5Cº No other cause of fever is detectable No severe malnutrition Guardian/patient has understood the procedures of the study and willing to participate Exclusion Criteria: Not able to drink or breastfeed Vomiting everything Recent history of convulsions Lethargic or unconscious Unable to sit or stand (as appropriate for age) History of allergy to test drugs History of intake of any drugs other than paracetamol and aspirin within 3 days Symptoms/signs of severe malaria

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>All treatment doses accompanied with intake of fatty food | Drug: artemether-lumefantrine<br>* All treatment doses given either accompanied or not-accompanied with intake of fatty food.<br>* Other names: All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food;|
| Active Comparator: 2<br>All treatment doses not-accompanied with intake of fatty food. | Drug: artemether-lumefantrine<br>* All treatment doses given either accompanied or not-accompanied with intake of fatty food.<br>* Other names: All drug doses of artemether-lumefantrine is given either accompanied with or not-accompanied with intake of fatty food;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading |  | 72 hours |