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Therapeutic Efficacy Study of AL and DP in Western Kenya

NCT05060198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2021-09-29

No results posted yet for this study

Summary

Artemether-lumefantrine (AL) was adopted as first-line antimalarial therapy in Kenya in 2006, and dihydroartemisinin-piperaquine (DP) as the second-line therapy in 2010. In order to monitor the efficacy and potential development of resistance of Plasmodium falciparum parasites to these two drugs, we will conduct an in-vivo study to monitor the efficacy of these antimalarial therapies.

A standardized World Health Organization (WHO) in-vivo efficacy study will be conducted in western Kenya among children 6-59 months of age with symptomatic, uncomplicated malaria visiting the out-patient department of hospitals and/or clinics in western Kenya.

In this study, 350 children will be randomly assigned to be treated with either AL or DP. Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period. Molecular analysis will be conducted to determine the frequency of markers of antimalarial resistance, and to differentiate recrudescence from reinfection. Results from this antimalarial drug efficacy study will be used to assist the Kenya national malaria control program (NMCP) in evaluating the national malaria treatment policy.

Conditions

  • Malaria,Falciparum

Interventions

DRUG

Artemether-lumefantrine (AL)

AL is the current first-line antimalarial in Kenya, per Kenya Ministry of Health.

DRUG

Dihydroartemisinin-piperaquine (DP)

DP is the current second-line antimalarial in Kenya, per Kenya Ministry of Health.

Sponsors & Collaborators

Principal Investigators

  • Simon Kariuki, PhD · Kenya Medical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-17
Primary Completion
2017-03-13
Completion
2020-12-31

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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 NCT05060198 on ClinicalTrials.gov