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

Liverpool School of Tropical Medicine

Status and phase: Unknown; Phase 4

Conditions: Malaria

Treatments: Drug: Artemether-lumefantrine combination

Study type: Interventional

Funder types: Other

Identifiers

NCT01038063

09.07

Details and patient eligibility

About

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).

Enrollment: 1,200 estimated patients

Sex: All

Ages: 4 to 48 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,200 participants in 2 patient groups

Artemether-lumefantrine

Experimental group

Description:

Children in this study arm will be treated with artemether-lumefantrine during a three year follow-up period each time a child develops uncomplicated malaria.

Treatment:

Drug: Artemether-lumefantrine combination

Dihydroartemisinin-piperaquine

Active Comparator group

Description:

Children in this study arm will be treated with dihydroartemisinin-piperaquine during a three year follow-up period each time a child develops uncomplicated malaria.

Treatment:

Drug: Artemether-lumefantrine combination