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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 2
Locations
Burkina Faso
Study Type
Interventional
Intervention
Amodiaquine
Sponsored by
Heidelberg University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria focused on measuring Amodiaquine, Efficacy, Malaria, Burkina Faso

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • Centre de Recherche en Santé de Nouna (CRSN)

Outcomes

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

Full Information

First Posted
November 30, 2005
Last Updated
February 2, 2010
Sponsor
Heidelberg University
Collaborators
Centre de Recherche en Sante de Nouna, Burkina Faso
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1. Study Identification

Unique Protocol Identification Number
NCT00261222
Brief Title
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

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University
Collaborators
Centre de Recherche en Sante de Nouna, Burkina Faso

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Amodiaquine, Efficacy, Malaria, Burkina Faso

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amodiaquine
Primary Outcome Measure Information:
Title
Total clinical failure rate on day 14.
Title
Clinical failure rate on day 14 in rural study area.
Title
Clinical failure rate on day 14 in urban study area.
Secondary Outcome Measure Information:
Title
Total clinical failure rate on day 28.
Title
Clinical failure rate on day 28 in rural study area.
Title
Clinical failure rate on day 28 in urban study area.
Title
Total early clinical failure rate.
Title
Early clinical failure rate in rural study area.
Title
Early clinical failure rate in urban study area.
Title
Total late parasitological failure rate on day 14 and 28.
Title
Late parasitological failure rate on day 14 and 28 in rural study area.
Title
Late parasitological failure rate on day 14 and 28 in urban study area.
Title
Incidence of observed and self-reported adverse events over the 28 days observation period
Title
Monitoring of concomitant drug intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Germain Mandi, MD
Organizational Affiliation
Centre de Recherche en Santé de Nouna
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olaf Mueller, MD, PhD
Organizational Affiliation
University of Heidelberg, Germany, Institute of Tropical Medecine and Public Health
Official's Role
Study Director
Facility Information:
Facility Name
Centre de Recherche en Santé de Nouna (CRSN)
City
Nouna
ZIP/Postal Code
P.O. Box 34
Country
Burkina Faso

12. IPD Sharing Statement

Learn more about this trial

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

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