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In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique | Clinical Trials | Clareo Health

COMPLETEDPHASE4

In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique

Monitoring the Therapeutic Efficacy of the Combinations Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Under 5 Years of Age in Five Sentinel Sites in Mozambique

NCT05343312•Centro de Investigacao em Saude de Manhica

View on ClinicalTrials.gov

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 four oral ACTS artemether-lumefantrine (AL), Amodiaquine-Artesunate (AQ-AS), Dihydroartemisinin-Piperaquine (DHP) and Pironaridine-Artesunate for the treatment of uncomplicated malaria in children aged\<5 years.

Detailed Description

Eligible patients were consecutively assigned to the cohort and treated with AL (cohort 1), AQ-AS (cohort 2), DHP (cohort 3) and PA (cohort 4). AL (Coartem™) will be 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 (Winthrop™) will be 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. DHP will be administered once daily according to body weight: half tablet (40mg dihydroartemisinin e 320 mg piperaquine) for children 5 to \< 10Kg, one tablet for per dose for those 10 \< 20Kg and 2 tablets for 20 or more Kg. PA (granules 60mg pirinaridine +/20mg artesunate) will administered once daily according to body weight: 1 granule per dose for children 5 to \< 8Kg, two for children 8 \< 15Kg, three for those 15 \< 20Kg. PA (180mg pyrinaridine+60 mg artesunate) one tablet for children 20 \< 24Kg and two tablets for those 24 \< 45Kg. All treatments will be directly observed for a minimum of 30 minutes. Vomiting occurring within the first 30 minutes implied the repetition of the full dose of treatment. For those patients living far away from the health facilities, and for which direct observation of the evening doses of AL was challenging, admission was offered for the first three days of the study.

Eligibility

Age

0 - 4 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

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

Locations (5)

Hospital Rural de Montepuez

Montepuez, Cabo Delgado Province, Mozambique

Hospital Distrital de Mssinga

Massinga, Inhambane Province, Mozambique

Hospital Distrital de Dondo

Dondo, Sofala, Mozambique

Mospital Distrital de Moatize

Moatize, Tete, Mozambique

Hospital Distrital de Mopeia

Mopeia, Zambezia Province, Mozambique

Key Dates

Start Date

March 16, 2022

Primary Completion Date

September 30, 2023

Completion Date

July 30, 2025

Last Updated

August 27, 2025

Enrollment

870

ACTUAL participants

Conditions

Malaria

Interventions

AL (Coartem)

DRUG

AS-AQ (Carsucam)

DRUG

DHP

DRUG

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Malaria (Plasmodium Falciparum)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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In Vivo Efficacy of Artemether-Lumefantrine, Amodiaquine-Artesunate, Dihydroartemisinin-Piperaquine, and Pironaridine-Artesunate in Mozambique

Inclusion Criteria

Exclusion Criteria

Dose Finding Trial of R21/Matrix-M in School Children

OPTImizing Malaria And HIV Treatment in a Shifting Landscape in Africa

Introduction of Polymerase Chain Reaction (PCR) in Microbiology and Parasitology

FocaL Mass Drug Administration for Vivax Malaria Elimination

A Study of Oral E1018 in Healthy Adult Participants

Laboratory Evaluation of Pregnancy Malaria Vaccine Candidates/In-vitro Testing of Pregnancy Malaria Vaccine Candidates