Malaria
Conditions
Brief summary
The purpose of this study is to assess the efficacy of artesuante + amodiaquine four years after its introduction as first line treatment for uncomplicated childhood malaria in Zanzibar. The hypothesis is that the treatment has a polymerase chain reaction (PCR)adjusted parasitological cure rate of at least 85% 42 days after treatment.
Interventions
Sponsors
Karolinska University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
Inclusion criteria
* Age below 60 months * Weight ≥5kg * No general danger signs or severe malaria present (see 4.4.2.1 & 4.4.2.2) * History of fever within 24 hours OR axillary temperature ≥ 37.5Cº * No other cause of fever is detectable * No severe malnutrition * Presence of P. falciparum asexual parasite density between 2000- 200,000/ul * Guardian/Patient has understood the procedures of the study and is willing to participate * Patient able to come for stipulated follow up visits and has easy access to the Study Site
Exclusion criteria
* Not able to drink or breastfeed * Persistent Vomiting * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PCR adjusted parasitological cure rate by day 42. | — |
Countries
Tanzania
Outcome results
None listed