Clinical trial NCT00261222: Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
Official title: Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Malaria
Keywords: Amodiaquine
Efficacy
Malaria
Burkina Faso
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Centre de Recherche en Sante de Nouna, Burkina Faso
First posted: 2005-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total clinical failure rate on day 14.
measure: Clinical failure rate on day 14 in rural study area.
measure: Clinical failure rate on day 14 in urban study area.
Secondary outcomes:
measure: Total clinical failure rate on day 28.
measure: Clinical failure rate on day 28 in rural study area.
measure: Clinical failure rate on day 28 in urban study area.
measure: Total early clinical failure rate.
measure: Early clinical failure rate in rural study area.
measure: Early clinical failure rate in urban study area.
measure: Total late parasitological failure rate on day 14 and 28.
measure: Late parasitological failure rate on day 14 and 28 in rural study area.
measure: Late parasitological failure rate on day 14 and 28 in urban study area.
measure: Incidence of observed and self-reported adverse events over the 28 days observation period
measure: Monitoring of concomitant drug intake
Other outcomes:
Locations:
city: Nouna
country: Burkina Faso
facility: Centre de Recherche en Santé de Nouna (CRSN)
Study officials:
affiliation: Centre de Recherche en Santé de Nouna
name: Germain Mandi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health
name: Olaf Mueller, MD, PhD
role: STUDY_DIRECTOR
References: