Malaria
Conditions
Keywords
Malaria, Plasmodium falciparum, artemether-lumefantrine, effectiveness
Brief summary
The purpose of this clinical trial is to assess the effectiveness of artemether-lumefantrine (Coartem®) treatment provided by community health workers against uncomplicated malaria in children under 5 years of age in Kibaha District, Tanzania, during an extended follow-up of 42 days. The hypothesis is that artemether-lumefantrine treatment provided by community health workers will result in less than 85% PCR-corrected parasitological effectiveness by day 42, mainly due to partial non-compliance to full standard 6-dose regimen of the drug.
Interventions
DRUGartemether-lumefantrine
Sponsors
Karolinska University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
Inclusion criteria
1. Aged \<5 years 2. Weight \>5 kg 3. Suffering from acute uncomplicated P. falciparum malaria confirmed by RDT. Later microscopy using Giemsa-stained thick film will be made to ensure asexual parasite density of 2000 to 200 000 parasites/µL 4. Having a history of fever in the preceding 24 h 5. Able to ingest tablets orally 6. Willing and able to attend stipulated follow-up visits 7. With written informed consent from parent/guardian for children to participate in the trial.
Exclusion criteria
Presenting with any of the following danger signs of severe malaria: 1. Convulsions (\>1 episode within previous 24 hours) 2. Lethargic/unconscious
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness (PCR adjusted parasitological cure rate) of artemether-lumefantrine | — |
| during 42 days follow-up. | — |
Countries
Tanzania
Outcome results
None listed