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

Study Overview
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Brief Summary
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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 Title
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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

Conditions
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Malaria, Falciparum

Intervention / Treatment
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* Drug: Artemether/lumefantrine tablets
* Drug: Artemether/Lumefantrine suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Initial parasite density of between 2,000 and 200,000 asexual parasites/µl of blood Not suffering from severe and complicated forms of malaria Able to take drugs under study by the oral route Parent or guardian gives informed written consent to participate in study Exclusion Criteria: 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 Signs of severe malnutrition (defined as follows: children with weight/height ratio below 3 standard deviations or below 70% of the median of the WHO standardized reference values, or still with symmetrical oedema affecting both feet) Presence of general danger signs in children below 5 years or other signs of serious and complex Plasmodium falciparum, as stated in the present WHO definitions Patients with known history of heart disease or arrhythmia History of allergy to artemether/lumefantrine or quinine

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Artemether/lumefantrine tablets<br>* 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<br>* Other names: Coartem;|
| Active Comparator: B<br> | Drug: Artemether/Lumefantrine suspension<br>* 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<br>* Other names: Co-Artesiane suspension;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare PCR corrected cure-rates on day 14 and 28 |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28 |  | 28 days | 
| To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28 |  | 28 days | 
| Monitor any possible adverse reactions following use of both drugs |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Artemether/Lumefantrine suspension, P. falciparum malaria, children, uncomplicated Plasmodium falciparum malaria