In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a classical in vivo clinical trial, following World Health organization's recommendations, ran as a multisite study within Mozambique trying to assess the efficacy and safety in 5 sites of the two oral ACTS artemether-lumefantrine (AL) and Amodiaquine-Artesunate (AQ-AS), first and second line treatment for malaria in mozambique, respectively, for the treatment of uncomplicated malaria in children aged<5 years.

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

Details

• Lead Sponsor: Centro de Investigacao em Saude de Manhica
• Collaborator: FHI 360
• Treatments: Amodiaquine; Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Artesunate; Lumefantrine

Criteria

Inclusion Criteria:

• Ages 6 to 59 months

• Weight Greater than or equal to 5 kg

• Absence of severe malnutrition;

• Mono-infection with Plasmodium falciparum in blood, confirmed by microscopy;

• Parasite density between 2,000 and 200,000 asexual parasites per microliter of blood;

• Axillary temperature ≥ 37.5 C° or history of fever in the last 24 hours;

• Lack of danger signs, or no signs of severe and / or complicated malaria according to the WHO definition

• Ability to swallow the drugs

• Haemoglobin greater than 5.0 g / dl

• Residents within the study area and have the possibility of an adequate follow-up in the days of monitoring for a period of 28 days;

• Absence of a history of hypersensitivity to study medications;

• Informed consent of parents, guardians or caregivers (legal guardian) after explaining the purpose of the study.

Exclusion Criteria:

• Presence of any danger sign or severe or complicated Plasmodium falciparum malaria according to WHO definitions

• Presence of fever due to diseases other than malaria (eg measles, acute respiratory infection, severe diarrhea with dehydration) or other known diseases, with chronic or serious illnesses (cardiac, renal, hepatic or known infection with HIV AIDS),

• Presence of severe malnutrition (defined as a child whose growth pattern is below the 3rd percentile, mid-upper-arm circumference <110mm, weight / height <70% according to the WHO tables, or the presence of bilateral edema of the lower limbs)

• Multi or mono-infection by another Plasmodium species detected by microscopy;

• Regular medication that may interfere with the pharmacokinetics of antimalarials;

• History of hypersensitivity or contraindication to study drug;

• A history of taking antimalarial drugs or drugs with antimalarial activity in less than 7 days.

• Continuous prophylaxis with cotrimoxazole in HIV positive children