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

Malaria, Falciparum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00529867
• Other study ID #: SSC protocol No. 1210
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2007
• Last updated: January 17, 2008
• Start date: May 2007
• Est. completion date: December 2007

Study information

• Verified date: January 2008
• Source: Dafra Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ethical Review CommitteeKenya: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 267
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Artemether/lumefantrine tablets
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
• Artemether/Lumefantrine suspension
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

Locations

Country	Name	City	State
Kenya	Chulaimbo Health Centre	Kisumu	Nyanza

Sponsors (2)

Lead Sponsor	Collaborator
Dafra Pharma	Kenya Medical Research Institute

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare PCR corrected cure-rates on day 14 and 28		1 year
Secondary	To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28		28 days
Secondary	To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28		28 days
Secondary	Monitor any possible adverse reactions following use of both drugs		28 days