In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children (MEFI_III)
MEFI_III
1 other identifier
interventional
630
1 country
6
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 two oral ACTS artemether-lumefantrine (AL) and Amodiaquine-Artesunate (AQ-AS), first line treatment for malaria in mozambique, for the treatment of uncomplicated malaria in children aged\<5 years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2018
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2019
CompletedFirst Submitted
Initial submission to the registry
April 9, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedMay 1, 2020
April 1, 2020
6 months
April 9, 2020
April 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the Day 28, PCR corrected cure rates of artemether-lumefantrine (Coartem) and Amodiaquine-artesunate (Coarsucam).
This cure rate is defined as the proportion of patients with adequate clinical and parasitological response (ACPR) at Day 28, once PCR correction to differentiate recrudescences from new infections have been applied (and hence only considering as treatment failures those parasite recurrences confirmed as recrudescences).
28 days
Secondary Outcomes (3)
to evaluate the incidence of adverse events
28 days
To measure the Day PCR uncorrected cure rates of Artemether-Lumefantrine and Amodiaquine-Artesunate
28 days
Evaluate the presence of Molecular Markers associated with sub optimum responses to ACTs
28 days
Study Arms (2)
Artemether-Lumefantrine
ACTIVE COMPARATOR4 sites, namely Massinga, Mopeia, Moatize and Montepuez
Amodiaquine-Artesunate
ACTIVE COMPARATOR3 sites, namely Massinga, Mopeia and Montepuez
Interventions
AL (Coartem™) was administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to \<15kg, two tablets per dose for those 15 to \<25kg, and three tablets per dose for those 25 to \<35kg.
AQ-AS (Coarsucam™) was administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children \<9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children \>18-35kg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital Rural de Montepuez
Montepuez, Cabo Delgado Province, Mozambique
Hospital Distrital da Massinga
Massinga, Inhambane Province, Mozambique
Centro de Investigaçao em Saude de Manhiça
Manhiça, Maputo Province, 1902, Mozambique
Centro de Investigação em Saúde de Manhiça
Manhiça, Maputo Province, CP1929, Mozambique
Hospital Distrital de Moatize
Moatize, Tete, Mozambique
Hospital Distrital de Mopeia
Mopeia, Zambezia Province, Mozambique
Related Publications (1)
Nhama A, Nhamussua L, Macete E, Bassat Q, Salvador C, Enosse S, Candrinho B, Carvalho E, Nhacolo A, Chidimatembue A, Saifodine A, Zulliger R, Lucchi N, Svigel SS, Moriarty LF, Halsey ES, Mayor A, Aide P. In vivo efficacy and safety of artemether-lumefantrine and amodiaquine-artesunate for uncomplicated Plasmodium falciparum malaria in Mozambique, 2018. Malar J. 2021 Oct 2;20(1):390. doi: 10.1186/s12936-021-03922-9.
PMID: 34600544DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eusebio Macete, MD, PhD
Centro de Investigacao em Saude de Manhica
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 9, 2020
First Posted
May 1, 2020
Study Start
March 21, 2018
Primary Completion
September 29, 2018
Study Completion
December 19, 2019
Last Updated
May 1, 2020
Record last verified: 2020-04