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

PHASE4CompletedINTERVENTIONAL
Enrollment

870

Participants

Timeline

Start Date

March 16, 2022

Primary Completion Date

September 30, 2023

Study Completion Date

July 30, 2025

Conditions
Malaria
Interventions
DRUG

AL (Coartem)

"Eligible patients will be consecutively assigned to the four cohorts. Rescue therapy according to national malaria treatment guidelines will be also administered in cases of early or late treatment failure.~Follow-up visits will take place on days 1, 2, 3, 7, 14,21 and 28 after enrolment or at any time point whenever the child is sick. Adverse events will be recorded and assessed for severity and association with study medication.~Thick and thin Giemsa-stained blood slides will be prepared before each dose to be administered and at every follow-up visit of days 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples for PCR analysis will be collected from every patient at baseline and at days 7, 14, 28, and 42 day of treatment failure or at any other unscheduled visit. The Molecular markers associated with suboptimal response to ACTs will be investigated."

DRUG

AS-AQ (Carsucam)

"Eligible patients will be consecutively assigned to the four cohorts. Rescue therapy according to national malaria treatment guidelines will be also administered in cases of early or late treatment failure.~Follow-up visits will take place on days 1, 2, 3, 7, 14,21, 28, 35 and 42 after enrolment or at any time point whenever the child is sick. Adverse events will be recorded and assessed for severity and association with study medication.~Thick and thin Giemsa-stained blood slides will be prepared before each dose to be administered and at every follow-up visit of days 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples for PCR analysis will be collected from every patient at baseline and at days 7, 14, and 28 day of treatment failure or at any other unscheduled visit. The Molecular markers associated with suboptimal response to ACTs will be investigated."

DRUG

DHP

"Eligible patients will be consecutively assigned to the four cohorts. Rescue therapy according to national malaria treatment guidelines will be also administered in cases of early or late treatment failure.~Follow-up visits will take place on days 1, 2, 3, 7, 14,21, 28, 35 and 42 after enrolment or at any time point whenever the child is sick. Adverse events will be recorded and assessed for severity and association with study medication.~Thick and thin Giemsa-stained blood slides will be prepared before each dose to be administered and at every follow-up visit of days 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples for PCR analysis will be collected from every patient at baseline and at days 7, 14, 28, and 42 day of treatment failure or at any other unscheduled visit. The Molecular markers associated with suboptimal response to ACTs will be investigated."

DRUG

PA

"Eligible patients will be consecutively assigned to the four cohorts. Rescue therapy according to national malaria treatment guidelines will be also administered in cases of early or late treatment failure.~Follow-up visits will take place on days 1, 2, 3, 7, 14,21, 28, 35 and 42 after enrolment or at any time point whenever the child is sick. Adverse events will be recorded and assessed for severity and association with study medication.~Thick and thin Giemsa-stained blood slides will be prepared before each dose to be administered and at every follow-up visit of days 2, 3, 7, 14, 21, 28, 35 and 42. Blood samples for PCR analysis will be collected from every patient at baseline and at days 7, 14, 28, and 42 day of treatment failure or at any other unscheduled visit. The Molecular markers associated with suboptimal response to ACTs will be investigated."

Trial Locations (5)

1999

Hospital Rural de Montepuez, Montepuez

Hospital Distrital de Mssinga, Massinga

Hospital Distrital de Dondo, Dondo

Mospital Distrital de Moatize, Moatize

Hospital Distrital de Mopeia, Mopeia

All Listed Sponsors
collaborator

United States Agency for International Development (USAID)

FED

lead

Centro de Investigacao em Saude de Manhica

OTHER