870
Participants
Start Date
March 16, 2022
Primary Completion Date
September 30, 2023
Study Completion Date
July 30, 2025
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."
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."
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."
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."
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
United States Agency for International Development (USAID)
FED
Centro de Investigacao em Saude de Manhica
OTHER