Treatment of Non-falciparum Malaria

Albert Schweitzer Hospital

Status: Completed

Conditions: Acute Non-falciparum Malaria

Treatments: Drug: artemether-lumefantrine

Study type: Interventional

Funder types: Other

Identifiers

NCT00725777

IDC-08-01

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 6 months to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

A

Experimental group

Treatment:

Drug: artemether-lumefantrine