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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dafra Pharma
• Collaborator: Kenya Medical Research Institute
• Treatments: Artemether; Artemether-lumefantrine combination; Artemether, Lumefantrine Drug Combination; Artemisinins; Lumefantrine

Criteria

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