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

L

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

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

Trial contacts and locations

1

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Central trial contact

David Lalloo, MD; Kamija Phiri, MD PhD

Data sourced from clinicaltrials.gov

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