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

NCT ID: NCT00261222

Last Updated: 2010-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2005-11-30

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.

Conditions

Malaria

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Amodiaquine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre de Recherche en Sante de Nouna, Burkina Faso

OTHER_GOV

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Principal Investigators

Germain Mandi, MD

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche en Santé de Nouna

Olaf Mueller, MD, PhD

Role: STUDY_DIRECTOR

University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health

Locations

Centre de Recherche en Santé de Nouna (CRSN)

Nouna, , Burkina Faso

Countries

Burkina Faso

Other Identifiers

SFB544-A8-AQ2005

Identifier Type: -

Identifier Source: org_study_id