Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00393679
Status:
COMPLETED
Last Update Posted:
2014-02-03
First Post:
2006-10-27
Brief Title:
Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children
Sponsor:
Institute of Tropical Medicine Belgium
Organization:
Institute of Tropical Medicine Belgium
Study Overview
Official Title:
Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children
Status:
COMPLETED
Status Verified Date:
2014-01
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:
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations ACT amodiaquine-artesunate AQAS dihydroartemisinin-piperaquine DHAPQ artemether-lumefantrine AL and chlorproguanildapsone plus artesunate for single and repeat treatments of uncomplicated malaria in children Safety will be determined by registering adverse events and grading laboratory and vital signs evaluations Their incidence will be compared between the different study arms
TO BE NOTED following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap Chlorproguanil-Dapsone and artesunate the Lapdap plus Artesunate arm was immediately discontinued in this study on 17th February 2008 A formal amendment has been submitted to all the concerned ECs and competent authorities The leading EC approved the amendment on 2nd June 2008
TO BE NOTED since the batches of the study drug DHAPQ expire at the end of October 2008 and because of the unavailability of a new batch of DHAPQ from the manufacturer the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008 A formal amendment has been submitted to all the concerned ECs and competent authorities
TO BE NOTED following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap Chlorproguanil-Dapsone and artesunate the Lapdap plus Artesunate arm was immediately discontinued in this study on 17th February 2008 A formal amendment has been submitted to all the concerned ECs and competent authorities The leading EC approved the amendment on 2nd June 2008
TO BE NOTED since the batches of the study drug DHAPQ expire at the end of October 2008 and because of the unavailability of a new batch of DHAPQ from the manufacturer the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008 A formal amendment has been submitted to all the concerned ECs and competent authorities
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB Antwerp 640187 | None | None | None |