In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children

PHASE4CompletedINTERVENTIONAL
Enrollment

700

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2013

Conditions
Malaria
Interventions
DRUG

Coartem™ (Artemether-lumefantrine combination)

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.

DRUG

Coarsucam™ (Amodiaquine-artesunate combination)

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.

Trial Locations (5)

Unknown

Hospital Rural de Montepuez, Montepuez

Hospital Rural de Chókwe,, Chokwé

Centro de Saúde de Dondo, Dondo

Hospital Provinvial de Tete, Tete

CP1929

Centro de Investigação em Saúde de Manhiça, Manhiça

All Listed Sponsors
collaborator

FHI 360

OTHER

lead

Centro de Investigacao em Saude de Manhica

OTHER

NCT02168569 - In Vivo Efficacy of Artemether-lumefantrine and Amodiaquine-artesunate in Mozambican Children | Biotech Hunter | Biotech Hunter