NCT01038063

Safety and Effectiveness of Artemisinin-based Combination Therapies (ACTs) With Repeated Treatments for Uncomplicated Falciparum Malaria Over a Three-year Period

Programmatic Implementation of ACTs in Malawi: Safety and Effectiveness of Combination Therapies With Repeated Treatments for Uncomplicated P. Falciparum Malaria Over a Three-year Period

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,200 (estimated)
• Sponsor: Liverpool School of Tropical Medicine · Academic / Other
• Sex: All
• Age: 4 Months – 48 Months
• Healthy volunteers: Not accepted

Summary

A community-based, open-label, cluster-randomised longitudinal study in which children are randomized according to village health worker catchment areas comparing the safety and effectiveness of repeated treatments with artemether-lumefantrine (AL) over a 3-year period in children 4-48 months to that of repeated treatment with dihydroartemisinin-piperaquine (DHA-PPQ).

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	Artemether-lumefantrine combination

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2009-12-23
• Last updated: 2010-12-09

Locations

1 site across 1 country: Malawi