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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00261222
Other study ID # SFB544-A8-AQ2005
Secondary ID
Status Completed
Phase Phase 2
First received November 30, 2005
Last updated February 2, 2010
Start date September 2005
Est. completion date November 2005

Study information

Verified date October 2006
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Burkina Faso: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date November 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 59 Months
Eligibility 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Amodiaquine


Locations

Country Name City State
Burkina Faso Centre de Recherche en Santé de Nouna (CRSN) Nouna

Sponsors (2)

Lead Sponsor Collaborator
Heidelberg University Centre de Recherche en Sante de Nouna, Burkina Faso

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total clinical failure rate on day 14.
Primary Clinical failure rate on day 14 in rural study area.
Primary Clinical failure rate on day 14 in urban study area.
Secondary Total clinical failure rate on day 28.
Secondary Clinical failure rate on day 28 in rural study area.
Secondary Clinical failure rate on day 28 in urban study area.
Secondary Total early clinical failure rate.
Secondary Early clinical failure rate in rural study area.
Secondary Early clinical failure rate in urban study area.
Secondary Total late parasitological failure rate on day 14 and 28.
Secondary Late parasitological failure rate on day 14 and 28 in rural study area.
Secondary Late parasitological failure rate on day 14 and 28 in urban study area.
Secondary Incidence of observed and self-reported adverse events over the 28 days observation period
Secondary Monitoring of concomitant drug intake
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