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Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria

NCT00529867 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 267

Last updated 2008-01-18

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and efficacy in children aged 6 - 59 months with uncomplicated malaria, treated with either conventional artemether/lumefantrine tablets(Coartem®) or artemether/ lumefantrine suspension (Co-artesiane®) in Western Kenya

Conditions

  • Malaria, Falciparum

Interventions

DRUG

Artemether/lumefantrine tablets

Artemether/lumefantrine tablets containing 20mg artemether and 120mg lumefantrine Dosage: 5 - 14.9 kg: 1 tablet and 15 - 24.9 kg: 2 tablets Administered at 0, 8, 24, 36, 48, and 60 hours on days 0, 1, and 2

DRUG

Artemether/Lumefantrine suspension

Artemether/lumefantrine suspension containing 15mg artemether and 90mg lumefantrine per 5ml suspension Dosage: 5.0 - 7.4 kg = 7 ml, 7.5 - 9.9 kg = 10 ml, 10 - 12.4 kg = 14 ml, 12.5 - 14.9 kg = 17 ml, 15 - 17.4 kg = 20 ml, 17.5 - 19.9 kg = 24 ml, 20 - 22.4 kg = 27 ml and 22.5 - 24.9 kg = 30 ml Administered once daily at 0, 24, and 48 hours on days 0, 1 and 2

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • Dafra Pharma

    lead INDUSTRY

Principal Investigators

  • Elizabeth A Juma, Dr. · 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
2007-05-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Kenya

Study Locations

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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 NCT00529867 on ClinicalTrials.gov