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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

Primary Purpose

Malaria

Status

Unknown status

Phase

Phase 4

Locations

Malawi

Study Type

Interventional

Intervention

Artemether-lumefantrine combination

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

4 Months - 48 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Malawi-Liverpool-Wellcome Trust Research Programme, College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Artemether-lumefantrine

Dihydroartemisinin-piperaquine

Arm 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.

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.

Outcomes

Primary Outcome Measures

Prevalence of ototoxicity at 18 months and 36 months of enrolment.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01038063

First Posted

December 21, 2009

Last Updated

December 8, 2010

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

1. Study Identification

Unique Protocol Identification Number

NCT01038063

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Unknown status

Study Start Date

October 2010 (undefined)

Primary Completion Date

September 2013 (Anticipated)

Study Completion Date

September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the 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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Artemether-lumefantrine

Arm Type

Experimental

Arm 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.

Arm Title

Dihydroartemisinin-piperaquine

Arm Type

Active Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Artemether-lumefantrine combination

Primary Outcome Measure Information:

Title

Prevalence of ototoxicity at 18 months and 36 months of enrolment.

Time Frame

At 18 mo and 36 month of follow up

Secondary Outcome Measure Information:

Title

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

Time Frame

18 and 36 months of follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Months

Maximum Age & Unit of Time

48 Months

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Lalloo, MD

Phone

+44 151 705 3179

dlalloo@liverpool.ac.uk

First Name & Middle Initial & Last Name or Official Title & Degree

Kamija Phiri, MD PhD

Phone

+265 999 957 048

kamijaphiri@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Lalloo, MD

Organizational Affiliation

Liverpool School of Tropical Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine

City

Blantyre

ZIP/Postal Code

30096

Country

Malawi

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kamija Phiri, MD PhD

Phone

+265 999 957 048

kamijaphiri@gmail.com

First Name & Middle Initial & Last Name & Degree

Kamija Phiri, MD PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

22232457

Citation

Roca-Feltrer A, Lalloo DG, Phiri K, Terlouw DJ. Rolling Malaria Indicator Surveys (rMIS): a potential district-level malaria monitoring and evaluation (M&E) tool for program managers. Am J Trop Med Hyg. 2012 Jan;86(1):96-8. doi: 10.4269/ajtmh.2012.11-0397.

Results Reference

derived

Links:

URL

http://www.actconsortium.org

Description

The ACT Consortium is a global research partnership formed in November 2007 to answer key questions on malaria drug delivery in Africa and Asia.

Learn more about this trial

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

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