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

Dafra Pharma

Status and phase

Completed

Phase 4

Conditions

Malaria, Falciparum

Treatments

Drug: Artemether/lumefantrine tablets

Drug: Artemether/Lumefantrine suspension

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00529867

SSC protocol No. 1210

Details and patient eligibility

About

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

Enrollment

267 patients

Sex

All

Ages

6 to 59 months old

Volunteers

No Healthy Volunteers

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