Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-26 @ 3:37 AM
Study NCT ID:
NCT00164359
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amodiaquine Plus Artesunate Versus Lapdap Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi
Sponsor:
Centers for Disease Control and Prevention
Organization:
Study Overview
Official Title:
A Double-blind Randomised Trial to Assess the Tolerability of Amodiaquine Plus Artesunate (AQ-Art) Versus Chlorproguanil Plus Dapsone Plus Artesunate (CDA) in the Treatment of Uncomplicated P. Falciparum 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 is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P. falciparum malaria parasite to this drug has led to an imminent need for the government of Malawi to identify a new first-line therapy for uncomplicated malaria and to implement that new therapy as policy. This protocol is the second of two protocols whose combined purpose is to provide efficacy and side effect data on four antimalarial drug combinations that are candidates for the next first-line therapy for uncomplicated malaria in Malawi. This protocol aims to assess the acceptability and tolerability of amodiaquine in Malawi. It is a double-blind study comparing amodiaquine plus artesunate (AQ-Art, one of the candidate combination therapies) to chlorproguanil/dapsone plus artesunate (CD-Art, another of the candidate combination therapies) in persons 5 years and older, to see if there is a higher incidence of abdominal pain and/or refusal to take the therapy in the AQ-Art group. Amodiaquine was removed from the Malawian national drug registry in 1995 because of a perceived association with abdominal pain. Although no studies were conducted to substantiate this, consensus among clinicians was that patients were refusing amodiaquine with increasing frequency, citing abdominal pain as the reason, so the drug was removed from the registry. Results from this study, along with the efficacy data from the sister protocol in children under five years of age, will help guide the National Malaria Control Program of Malawi in selecting their next first-line antimalarial therapy.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| PA#04018 | None | None | View |