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Evaluation of the Efficacy of Artemisinin Combination Therapy in Kenya

NCT01899820 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2100

Last updated 2013-10-08

No results posted yet for this study

Summary

Artemisinin-based combination therapies (ACTs) are recommended for use against uncomplicated malaria in areas of multi-drug resistant malaria. The Ministry of Health, Division of Malaria Control (DOMC) rolled out the use of artemether-lumefantrine as the first line treatment for uncomplicated malaria in 2006.The development of the ACTs and its derivatives are the most rapidly acting of all the current antimalarial drugs and recognition of their potential role as a component of combination therapy have led to several large trials aimed at assessing different combinations of existing drugs, and to the specific development of new combination drugs.

This proposal aims to (1) evaluate the efficacy of artemisinin-based anti-malaria combination drugs in different sites across Kenya (2) elucidate the markers of resistance to ACTs through molecular genetics and in this process further strengthen capacity in the proposed study sites as well as improve links between research and control ultimately to influence malaria treatment policy and practice.

Five groups in East Africa will conduct a multi-centre, randomised, two arm trial to assess the efficacy of dihydroartemisin-piperaquine with artemether-lumefantrine as the comparative drug. The network will determine antimalarial drug efficacy using standardised protocols and collate clinical responses and adverse events. Molecular markers to artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles in drug failure cases. Recrudescence or re-infections will be differentiated by analysis of the MSP1, MSP2 and GLURP genes and assess transmission dynamics post treatment. Data from these studies will be captured into a database developed by the network. The latter offers several advantages including

* Working towards the standardization of methodologies and common protocols as a way of comparing data across sites
* Pulling together datasets and conduct a multi-centre analysis
* Sharing and coordinating quality assurance mechanisms

Conditions

Interventions

DRUG

Artemether lumefantrine

Artemether 20mg Lumefantrine 120mg

DRUG

Dihydroartemisinin piperaquine

Dihydroartemisinin 20mg Piperaquine 160mg

Sponsors & Collaborators

  • World Bank

    collaborator OTHER

  • Kenya Medical Research Institute

    collaborator OTHER

  • Sabah Ahmed Omar

    lead OTHER

Principal Investigators

  • Sabah A Omar, PhD · KEMRI CGMR-C

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-06-30
Completion
2015-07-31

Countries

  • Kenya

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 NCT01899820 on ClinicalTrials.gov