Medical Research Unit of the Albert Schweitzer Hospital
Lambaréné, Moyen-Ogooué Province, BP 118, Gabon
Completed
NCT Number: NCT00725777
Treatment of Non-falciparum Malaria
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.
Completed
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Conditions
Age range
6 month–60 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Artemether-lumefantrine
DrugStandard artemether-lumefantrine treatment
Primary outcomes
-
Parasitological cure rate on day 28
Time frame: D28
Secondary outcomes
-
Frequency and severity of drug related adverse events
Time frame: D28
Sponsors and collaborators
Lead sponsor
Albert Schweitzer Hospital
Other
Registry information
Official study title
Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon
Important dates
- Study start
- 2008
- Primary completion
- 2011
- Study completion
- 2012
- First posted
- Jul 30, 2008
- Registry last updated
- Feb 17, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.