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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01038063
• Other study ID #: 09.07
• Status: Recruiting
• Phase: Phase 4
• First received: December 21, 2009
• Last updated: December 8, 2010
• Start date: October 2010
• Est. completion date: September 2013

Study information

• Verified date: December 2010
• Source: Liverpool School of Tropical Medicine
• Contact: David Lalloo, MD
• Phone: +44 151 705 3179
• Email: dlalloo[@]liverpool.ac.uk
• Is FDA regulated: No
• Health authority: Malawi: College of Medicine Research and Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Months to 48 Months

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Artemether-lumefantrine combination

Locations

Country	Name	City	State
Malawi	Malawi-Liverpool-Wellcome Trust Research Programme, College of Medicine	Blantyre

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool School of Tropical Medicine	Malawi-Liverpool-Wellcome Trust Clinical Research Programme, College of Medicine, National Malaria Control Programme, Malawi, Research for Equity and Community Health Trust

Country where clinical trial is conducted

Malawi, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of ototoxicity at 18 months and 36 months of enrolment.		At 18 mo and 36 month of follow up	Yes
Secondary	Incidence of clinical malaria during 18 months and 36 months of follow-up		18 and 36 months of follow up	No

External Links

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