Acute Non-falciparum Malaria
Conditions
Brief summary
Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.
Interventions
DRUGartemether-lumefantrine
Standard artemether-lumefantrine treatment
Sponsors
Albert Schweitzer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 60 Years
Healthy volunteers
No
Inclusion criteria
* Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight * Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density \> 50-200000/μl of blood * Written informed consent
Exclusion criteria
* Patients with presence of other clinical conditions requiring hospitalization * Presence of other febrile conditions * Presence of significant anemia, defined by hemoglobin \< 7g/dl * Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine * Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks * Pregnant and breast feeding females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parasitological cure rate on day 28 | D28 |
Secondary
| Measure | Time frame |
|---|---|
| Frequency and severity of drug related adverse events | D28 |
Countries
Gabon
Outcome results
None listed