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

NCT01038063 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1200

Last updated 2010-12-09

No results posted yet for this study

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).

Conditions

Interventions

DRUG

Artemether-lumefantrine combination

Sponsors & Collaborators

  • Malawi-Liverpool-Wellcome Trust Clinical Research Programme

    collaborator OTHER
  • National Malaria Control Programme, Malawi

    collaborator OTHER_GOV
  • Research for Equity and Community Health Trust

    collaborator UNKNOWN
  • Liverpool School of Tropical Medicine

    lead OTHER

Principal Investigators

  • David Lalloo, MD · Liverpool School of Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-09-30
Completion
2013-09-30

Countries

  • Malawi

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01038063 on ClinicalTrials.gov