Completed
A Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya
What is being tested
Artemether/lumefantrine tablets
+ Artemether/Lumefantrine suspension
Drug
Who is being recruted
Vector Borne Diseases+4
+ Mosquito-Borne Diseases
+ Infections
From 6 to 59 Months
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: May 2007
Summary
Principal SponsorDafra Pharma
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: May 1, 2007
Actual date on which the first participant was enrolled.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
Official TitleA Randomized Open-Label Trial of the Efficacy of Artemether-Lumefantrine Suspension Compared With Artemether-Lumefantrine Tablets for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Less Than Five Years in Western Kenya
Principal SponsorDafra Pharma
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
267 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 6 to 59 Months
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Vector Borne DiseasesMosquito-Borne DiseasesInfectionsMalariaParasitic DiseasesProtozoan InfectionsMalaria, Falciparum
Criteria
8 inclusion criteria required to participate
Children aged between 6 and 59 months
Minimum body weight of 5kg
Presence of fever (Temp >/= 37.5°C) or a history of fever in the last 24 hours
Presence of asexual P. falciparum monoinfection
Show More Criteria
8 exclusion criteria prevent from participating
Severe and/or complicated malaria (WHO, 2000 classification), including severe anaemia (Hb =/<5 g/dl), two or more seizures in last 24 hrs and hyper-parasitaemia (>200,000 µl)
Patients treated with mefloquine, halofantrine within the 7 days before Day 0 or with quinine salts and artemisinin derivatives within 3 days before Day 0, or artemether-lumefantrine 30 days before Day 0
Patients who require intensive care for malaria or another severe concomitant illness capable of interfering with the clinical evolution of malaria
Patients with vomiting and/or diarrhoea
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center