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

• Status: Unknown status
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Liverpool School of Tropical Medicine
• Collaborators: Malawi-Liverpool-Wellcome Trust Clinical Research Programme; National Malaria Control Programme, Malawi; Research for Equity and Community Health Trust
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Dihydroartemisinin; Lumefantrine; Piperaquine

Criteria

Inclusion criteria

1. Aged between 4 months and 11 months at the time of randomization

2. Bodyweight ≥ 5 kg at the time of randomization

3. Provision of informed consent by parent or guardian

4. Intention to stay in the study area for the time of the study

Exclusion criteria

1. Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products

2. Intent to reside outside of catchment area during the course of the study

3. Known hypersensitivity to the study drug randomized to

4. Known pre-existing hearing problem or neurological impairment

5. Known need at the time of randomization for concomitant prohibited medication

6. Suspected non-compliance with the follow-up schedule