Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01082731
Status:
TERMINATED
Last Update Posted:
2012-04-13
First Post:
2010-03-08
Brief Title:
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P Falciparum in Pregnancy in Brazil
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
A Multi-center Open-label Randomized Phase 4 Trial of Artemether-Lumefantrine and Mefloquine-Artesunate for the Treatment of Uncomplicated P Falciparum Malaria Parasitemia in Pregnant Women in Brazil
Status:
TERMINATED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Extremely slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PAACT-PF
Brief Summary:
Data on the burden of MIP in low transmission areas such as Latin America are very limited there is even less information on the efficacy of case management of MiP The treatment recommendations for MiP in Latin American countries have been changing rapidly in recent months currently either artemether-lumefantrine AL or mefloquine-artesunate MA is the first line treatment for P falciparum depending on country however no data exists on the efficacy of these drugs for the treatment of malaria in pregnancy in Latin America to support their use
We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety and efficacy of the present therapies AL and MA We hypothesize that the drugs will both be efficacious for use in pregnant women in Brazil
We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety and efficacy of the present therapies AL and MA We hypothesize that the drugs will both be efficacious for use in pregnant women in Brazil
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