Malaria
Conditions
Brief summary
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.
Interventions
DRUGartemether-lumefantrine
All treatment doses given either accompanied or not-accompanied with intake of fatty food.
Sponsors
Muhimbili University of Health and Allied Sciences
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 10 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of P.falciparum genotypes identified at baseline compared with accumulated number of genotypes in all blood samples | 72 hours |
Secondary
| Measure | Time frame |
|---|---|
| Clearance kinetics of P. falciparum measured with PCR genotyping compared with blood slide reading | 72 hours |
Countries
Tanzania
Outcome results
None listed