Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso

Heidelberg University120 enrolled

Overview

Design: Single-centre Indication: Malaria caused by Plasmodium falciparum Objectives: To determine and compare the efficacy of AQ treatment in young children with uncomplicated falciparum malaria in the rural and the urban study area of the Centre de Recherche en Santé de Nouna (CRSN). Population: Children aged 6-59 months with uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C + ≥ 2.000 P. falciparum asexual parasites per µl blood) from the health centre situated in the villages of Bagala, Bourasso and Kemena and from Nouna town hospital outpatient department. Sample size: N=120 Treatment: All children will receive a total dose of 25 mg/kg oral AQ over a period of three days (first and second day: 10mg/kg, third day: 5mg/kg). Statistical procedures: The primary analysis parameter is the proportion of clinical failures on day 14. Secondary parameters are the rate of clinical failures on day 28 (with and without PCR correction), the rate of early clinical failures, the rate of late parasitological failures (day 14 and day 28), and the rate of adverse events. Data will be analysed in the overall group of study children and for rural (n=50) and urban (n=50) study children separately. Study duration and dates: The study will be implemented in September-December 2005.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Malaria

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 59 Months

Medical Language ↔ Plain English

Inclusion Criteria: * Age 6-59 months * Uncomplicated falciparum malaria (axillary temperature ≥ 37.5°C and ≥ 2.000 P. falciparum asexual parasites per µl blood) * Written informed consent given by the parents/caretakers Exclusion Criteria: * Complicated or severe malaria (repeated vomiting, seizures or other neurological impairment, haemoglobin \< 7 g/dl or haematocrit \< 21%) * Any apparent significant disease (e. g. pneumonia, meningitis, hepatitis, severe diarrhoea, measles, severe malnutrition) * Malaria treatment with western drugs and/or antibiotics with anti malarial potency during last 7 days except chloroquine.

Outcomes

Primary Outcomes

Total clinical failure rate on day 14.

Clinical failure rate on day 14 in rural study area.

Clinical failure rate on day 14 in urban study area.

Secondary Outcomes

Total clinical failure rate on day 28.

Clinical failure rate on day 28 in rural study area.

Clinical failure rate on day 28 in urban study area.

Total early clinical failure rate.

Early clinical failure rate in rural study area.

Early clinical failure rate in urban study area.

Total late parasitological failure rate on day 14 and 28.

Late parasitological failure rate on day 14 and 28 in rural study area.

Late parasitological failure rate on day 14 and 28 in urban study area.

Incidence of observed and self-reported adverse events over the 28 days observation period

Monitoring of concomitant drug intake