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

Phase 4

Completed

• Conditions: Malaria, Falciparum
• Interventions: Drug: Artemether/lumefantrine tablets; Drug: Artemether/Lumefantrine suspension

• Registration Number: NCT00529867
• Lead Sponsor: Dafra Pharma

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-09-12
• Study First Submitted QC: 2007-09-12
• Study First Posted: 2007-09-14
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-17
• Last Update Posted: 2008-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 267

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Artemether/lumefantrine tablets	-
B	Artemether/Lumefantrine suspension	-

Primary Outcome Measures

Name	Time	Method
To compare PCR corrected cure-rates on day 14 and 28	1 year

Secondary Outcome Measures

Name	Time	Method
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
To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28	28 days

Trial Locations

Locations (1)

Chulaimbo Health Centre; 🇰🇪 Kisumu, Nyanza, Kenya