Clinical trial NCT00529867: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria, Falciparum
Keywords: Artemether/Lumefantrine suspension
P. falciparum malaria
children
uncomplicated Plasmodium falciparum malaria
Lead sponsor: Dafra Pharma
Sponsor class: INDUSTRY
Collaborators: name: Kenya Medical Research Institute
First posted: 2007-09-14
Enrollment: 267
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: To compare PCR corrected cure-rates on day 14 and 28
timeFrame: 1 year
Secondary outcomes:
measure: To determine and compare Adequate Clinical and Parasitological Response (ACPR) at days 14 and 28
timeFrame: 28 days
measure: To determine and compare proportion of children with gametocytes on days 0, 7, 14, and 28
timeFrame: 28 days
measure: Monitor any possible adverse reactions following use of both drugs
timeFrame: 28 days
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Chulaimbo Health Centre
state: Nyanza
Study officials:
affiliation: Kenya Medical Research Institute
name: Elizabeth A Juma, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.