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

Sponsor

Heidelberg University (Other)

Overall Status

Completed

CT.gov ID

NCT00261222

Collaborator

Centre de Recherche en Sante de Nouna, Burkina Faso (Other)

120

Enrollment

Location

Duration (Months)

59.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Amodiaquine	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2005

Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de Recherche en Santé de Nouna (CRSN)	Nouna		Burkina Faso	P.O. Box 34

Sponsors and Collaborators

Heidelberg University
Centre de Recherche en Sante de Nouna, Burkina Faso

Investigators

Principal Investigator: Germain Mandi, MD, Centre de Recherche en Santé de Nouna
Study Director: Olaf Mueller, MD, PhD, University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health