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

December 8, 2010 updated by: Liverpool School of Tropical Medicine

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malawi
      • Blantyre, Malawi, 30096
        • Recruiting
        • Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine
        • Contact:
        • Principal Investigator:
          • Kamija Phiri, MD PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Artemether-lumefantrine
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.
Drug: Artemether-lumefantrine combination
Active Comparator: Dihydroartemisinin-piperaquine
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.
Drug: Artemether-lumefantrine combination

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of clinical malaria during 18 months and 36 months of follow-up
Time Frame: 18 and 36 months of follow up
18 and 36 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool School of Tropical Medicine

Collaborators

Malawi-Liverpool-Wellcome Trust Clinical Research Programme
National Malaria Control Programme, Malawi
Research for Equity and Community Health Trust

Investigators

  • Principal Investigator: David Lalloo, MD, Liverpool School of Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

December 21, 2009

First Submitted That Met QC Criteria

December 22, 2009

First Posted (Estimate)

December 23, 2009

Study Record Updates

Last Update Posted (Estimate)

December 9, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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