Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261222
Status:
COMPLETED
Last Update Posted:
2010-02-03
First Post:
2005-11-30
Brief Title:
Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
Sponsor:
Heidelberg University
Organization:
Heidelberg University
Study Overview
Official Title:
Efficacy of Amodiaquine in the Treatment of Uncomplicated Falciparum Malaria in Young Children of Burkina Faso
Status:
COMPLETED
Status Verified Date:
2006-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 375C 2000 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 N120
Treatment All children will receive a total dose of 25 mgkg oral AQ over a period of three days first and second day 10mgkg third day 5mgkg
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 n50 and urban n50 study children separately
Study duration and dates The study will be implemented in September-December 2005
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 375C 2000 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 N120
Treatment All children will receive a total dose of 25 mgkg oral AQ over a period of three days first and second day 10mgkg third day 5mgkg
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 n50 and urban n50 study children separately
Study duration and dates The study will be implemented in September-December 2005
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None