Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164710
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-09-13
Brief Title:
Assessing the Efficacy of Four Drug Combinations as the Next First-line Therapy for Uncomplicated Malaria in Malawi
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
An Open Randomised Trial of the Efficacy of Sulfadoxine-Pyrimethamine SP Amodiaquine SP AQ-SP AQ Artesunate AQ-Art Chlorproguanil-Dapsone Art CD-Art and Lumefantrine-Artemether LA for Uncomplicated Malaria in Malawi
Status:
COMPLETED
Status Verified Date:
2012-09
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:
Sulfadoxine-pyrimethamine SP is the current first-line treatment for uncomplicated malaria in Malawi The malaria parasite P falciparum has developed resistance to this drug so that the drug is much less effective than in previous years This study was developed and conducted in collaboration with the National Malaria Control Programme of Malawi to assess the efficacy of four antimalarial drug combinations to provide evidence to assist the Malawian Ministry of Health in identifying and implementing as policy the next first-line antimalarial for uncomplicated malaria in Malawi In an open randomized trial in children under five years of age four drug combinations all of which are licensed in Malawi are being assessed amodiaquine plus sulfadoxine-pyrimethamine AQ-SP amodiaquine plus artesunate AQ-Art chlorproguanil-dapsone plus artesunate CD-Art and lumefantrine-artemether LA SP is also included as a fifth arm of the study for current data on its efficacy Data on side effects of the drugs will also be collected The results of this study will provide some of the information necessary to guide the Malawi National Malaria Control Program in selecting its next first antimalarial treatment for uncomplicated malaria The study adheres to the World Health Organizations 2003 standardized protocol for assessing antimalarial drug efficacy
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 |
|---|---|---|---|
| PA 04018 | None | None | None |