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

January 17, 2008 updated by: Dafra Pharma

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

267

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
    • Nyanza
      • Kisumu, Nyanza, Kenya, 40100
        • Chulaimbo Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
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

Other Names:
  • Coartem
Active Comparator: B
Drug: 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

Other Names:
  • Co-Artesiane suspension

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dafra Pharma

Collaborators

Kenya Medical Research Institute

Investigators

  • Principal Investigator: Elizabeth A Juma, Dr., Kenya Medical Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

September 12, 2007

First Submitted That Met QC Criteria

September 12, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Estimate)

January 18, 2008

Last Update Submitted That Met QC Criteria

January 17, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSC protocol No. 1210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malaria, Falciparum

Clinical Trials on Artemether/lumefantrine tablets

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe