Artemisinin-based Combination Therapy for Treatment of Plasmodium Falciparum Malaria in North Sumatera, Indonesia

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open label, randomised controlled trial to assess the safety and efficacy of dihydroartemisinin-piperaquine and artemether-lumefantrine in children and adults with uncomplicated Plasmodium falciparum malaria infection. Molecular markers for antimalarial resistance will also be assessed and the presence of molecular markers in the parasites will be associated with treatment outcomes.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborators: Universitas Sumatera Utara; University of Sumatera Utara
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinine; Artemisinins; Artenimol; Dihydroartemisinin; Lumefantrine; Piperaquine

Criteria

Inclusion Criteria:

• Male or female

• All patients per 6 months of age

• Fever as defined by axillary temperature > 37.5 C or history of fever during the 48 hours before recruitment

• Infection with P. falciparum detected by microscopy

• Parasitaemia > 250 /uL blood

• Ability to swallow oral medication

• Ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule

• Informed consent from the patient or from a parent or guardian in the case of children

• Absence of history to hypersensitive reactions or contraindication to antimalarial drugs

• Not currently consuming antibiotic with antimalarial activity (such as cotrimoxazole, macrolides, tetracycline or doxycycline)

Exclusion Criteria:

• Presence of general danger signs in children under 5 years or signs of severe falciparum malaria according to the definitions of WHO (2000)

• Presence of severe malnutrition according to WHO child growth standards

• Presence of febrile conditions caused by diseases other than malaria

• Presence of severe anemia (Hemoglobin < 7 gr/dL)

• Received any of the study drugs within the past 4 weeks

• Received any antimalarial within the last 2 weeks

• Recurrent vomiting )necessitating more than a single repeat dose)

• Pregnant (demonstrated by positive result of b-HCG in women of childbearing age

• Lactating mother