Status:
COMPLETED
In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children (MEFI_III)
Lead Sponsor:
Centro de Investigacao em Saude de Manhica
Collaborating Sponsors:
United States Agency for International Development (USAID)
Conditions:
Malaria
Eligibility:
All Genders
6-59 years
Phase:
PHASE4
Brief 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 4 sites of the...
Detailed Description
This study followed WHO recommendations for in vivo antimalarial efficacy trials. The study population comprised children aged 6 to 59 months with microscopically confirmed acute uncomplicated malari...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2019
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT04370977
Start Date
March 21 2018
End Date
December 19 2019
Last Update
May 1 2020
Active Locations (6)
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1
Hospital Rural de Montepuez
Montepuez, Cabo Delgado Province, Mozambique
2
Hospital Distrital da Massinga
Massinga, Inhambane Province, Mozambique
3
Centro de Investigaçao em Saude de Manhiça
Manhiça, Maputo Province, Mozambique, 1902
4
Centro de Investigação em Saúde de Manhiça
Manhiça, Maputo Province, Mozambique, CP1929