Randomised Efficacy Study of Two Artemether-Lumefantrine Oral Formulations for the Treatment of Uncomplicated P. Falciparum Malaria
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
1 other identifier
interventional
267
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2007
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 12, 2007
CompletedFirst Posted
Study publicly available on registry
September 14, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedJanuary 18, 2008
January 1, 2008
7 months
September 12, 2007
January 17, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare PCR corrected cure-rates on day 14 and 28
1 year
Secondary Outcomes (3)
To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28
28 days
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
Study Arms (2)
A
ACTIVE COMPARATORB
ACTIVE COMPARATORInterventions
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 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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dafra Pharmalead
- Kenya Medical Research Institutecollaborator
Study Sites (1)
Chulaimbo Health Centre
Kisumu, Nyanza, 40100, Kenya
Related Publications (2)
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.
PMID: 33289099DERIVEDJuma 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.
PMID: 19102746DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth A Juma, Dr.
Kenya Medical Research Institute
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 12, 2007
First Posted
September 14, 2007
Study Start
May 1, 2007
Primary Completion
December 1, 2007
Study Completion
December 1, 2007
Last Updated
January 18, 2008
Record last verified: 2008-01