Status:
COMPLETED
Efficacy of Artemether-Lumefantrine in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 12 Years at Four Sentinel Sites in Mozambique
Lead Sponsor:
Centro de Investigacao em Saude de Manhica
Collaborating Sponsors:
World Health Organization (Mozambique)
National Malaria Control Program (NMCP), Mozambique
Conditions:
Malaria (Uncomplicated)
Eligibility:
All Genders
6-11 years
Phase:
NA
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 four sites of ...
Detailed Description
Eligible patients were consecutively assigned to the cohort and treated with AL. AL (Coartem™) will be administered twice daily for three days (six doses in total) with dosage determined according to ...
Eligibility Criteria
Inclusion
- Ages 6 to 143 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 1,000 and 200,000 asexual parasites per microliter of blood;
- Haemoglobin ≥ 7.0 g/dl;
- 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
- 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 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT06970600
Start Date
March 7 2024
End Date
January 31 2025
Last Update
May 14 2025
Active Locations (4)
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1
Hospital Distrital de Massinga
Massinga, Inhambane Province, Mozambique
2
Hospital Rural de Cuamba
Cuamba, Niassa Province, Mozambique
3
Hospital Distrital de Dondo
Dondo, Sofala, Mozambique
4
Hospital Distrital de Mopeia
Mopeia, Zambezia Province, Mozambique