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

Primary Purpose

Malaria, Falciparum

Status
Completed
Phase
Phase 4
Locations
Kenya
Study Type
Interventional
Intervention
Artemether/lumefantrine tablets
Artemether/Lumefantrine suspension
Sponsored by
Dafra Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria, Falciparum focused on measuring Artemether/Lumefantrine suspension, P. falciparum malaria, children, uncomplicated Plasmodium falciparum malaria

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept 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

Sites / Locations

  • Chulaimbo Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

Outcomes

Primary Outcome Measures

To compare PCR corrected cure-rates on day 14 and 28

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2007
Last Updated
January 17, 2008
Sponsor
Dafra Pharma
Collaborators
Kenya Medical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00529867
Brief Title
Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dafra Pharma
Collaborators
Kenya Medical Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
Artemether/Lumefantrine suspension, P. falciparum malaria, children, uncomplicated Plasmodium falciparum malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Artemether/lumefantrine tablets
Other Intervention Name(s)
Coartem
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Artemether/Lumefantrine suspension
Other Intervention Name(s)
Co-Artesiane suspension
Intervention Description
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
Primary Outcome Measure Information:
Title
To compare PCR corrected cure-rates on day 14 and 28
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28
Time Frame
28 days
Title
To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28
Time Frame
28 days
Title
Monitor any possible adverse reactions following use of both drugs
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth A Juma, Dr.
Organizational Affiliation
Kenya Medical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chulaimbo Health Centre
City
Kisumu
State/Province
Nyanza
ZIP/Postal Code
40100
Country
Kenya

12. IPD Sharing Statement

Citations:
PubMed Identifier
33289099
Citation
Belard S, Ramharter M, Kurth F. Paediatric formulations of artemisinin-based combination therapies for treating uncomplicated malaria in children. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009568. doi: 10.1002/14651858.CD009568.pub2.
Results Reference
derived
PubMed Identifier
19102746
Citation
Juma EA, Obonyo CO, Akhwale WS, Ogutu BR. A randomized, open-label, comparative efficacy trial of artemether-lumefantrine suspension versus artemether-lumefantrine tablets for treatment of uncomplicated Plasmodium falciparum malaria in children in western Kenya. Malar J. 2008 Dec 22;7:262. doi: 10.1186/1475-2875-7-262.
Results Reference
derived

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

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