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

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

  • Aged between 4 months and 11 months at the time of randomization
  • Bodyweight ≥ 5 kg at the time of randomization
  • Provision of informed consent by parent or guardian
  • Intention to stay in the study area for the time of the study

Exclusion criteria

  • Ongoing participation into another clinical study involving ongoing or scheduled treatment with medicinal products
  • Intent to reside outside of catchment area during the course of the study
  • Known hypersensitivity to the study drug randomized to
  • Known pre-existing hearing problem or neurological impairment
  • Known need at the time of randomization for concomitant prohibited medication
  • 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

Kamija Phiri, MD PhD; David Lalloo, MD

Data sourced from clinicaltrials.gov

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