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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01038063

Enrollment

1200

Registered

2009-12-23

Start date

2010-10-31

Completion date

2013-09-30

Last updated

2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria

Brief 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).

Interventions

DRUGArtemether-lumefantrine combination

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Months to 48 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Prevalence of ototoxicity at 18 months and 36 months of enrolment.	At 18 mo and 36 month of follow up

Secondary

Measure	Time frame
Incidence of clinical malaria during 18 months and 36 months of follow-up	18 and 36 months of follow up

Countries

Malawi

Contacts

Primary ContactDavid Lalloo, MD

dlalloo@liverpool.ac.uk+44 151 705 3179

Backup ContactKamija Phiri, MD PhD

kamijaphiri@gmail.com+265 999 957 048

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026