Malaria, Falciparum
Conditions
Keywords
Artemether/Lumefantrine suspension, P. falciparum malaria, children, uncomplicated Plasmodium falciparum malaria
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
Interventions
DRUGArtemether/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
DRUGArtemether/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
Sponsors
Kenya Medical Research Institute
Dafra Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 59 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare PCR corrected cure-rates on day 14 and 28 | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Kenya
Outcome results
None listed