Treatment of Non-falciparum Malaria
Not Applicable
Completed
- Conditions
- Acute Non-falciparum Malaria
- Interventions
- Registration Number
- NCT00725777
- Lead Sponsor
- Albert Schweitzer Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A artemether-lumefantrine -
- Primary Outcome Measures
Name Time Method Parasitological cure rate on day 28 D28
- Secondary Outcome Measures
Name Time Method Frequency and severity of drug related adverse events D28
Trial Locations
- Locations (1)
Medical Research Unit of the Albert Schweitzer Hospital
🇬🇦Lambaréné, Moyen Ogooue, Gabon