Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06300970
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-02-13
Brief Title:
Efficacy of Artesunate-amodiaquine and Artemether-lumefantrine for Treatment of Plasmodium Falciparum Malaria in Liberia
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Efficacy of Artesunate-amodiaquine ASAQ and Artemether-lumefantrine AL for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Liberia
Status:
COMPLETED
Status Verified Date:
2024-05
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:
To assess the efficacy of both first-line antimalarial medications used for the treatment of uncomplicated Plasmodium falciparum malaria infections in two geographic regions in Liberia
Detailed Description:
Title Efficacy of artesunateamodiaquine ASAQ and artemetherlumefantrine AL for the treatment of uncomplicated Plasmodium falciparum malaria in Liberia
Objective To assess the efficacy of both first-line ASAQ and AL for the treatment of uncomplicated P falciparum malaria infections
Study Sites Sacleapea Comprehensive Health Center Saclepea-Mah District in Nimba County and Sinje Health Center Garwula District Sinje in Grand Cape Mount County
Study Period August 2022 to August 2023
Study Design Prospective study of two cohorts with simultaneous enrolment of each therapy
Patient population Patients aged 6 to 59 months with confirmed uncomplicated P falciparum infection
Sample Size Total number of patients to be enrolled is 352 patients This consists of 88 patients per arm per site There are two arms in each of the two sites
Treatments and follow-up Patients enrolled in the ASAQ arm will receive the treatment once daily dose for three days Patients enrolled in the AL arm will receive treatment twice daily dose for three days Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy
Primary endpoints The proportion of patients with early treatment failure late clinical failure late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy Recrudescence will be distinguished from re-infection by polymerase chain reaction PCR analysis
Secondary endpoints The frequency and nature of adverse events will be recorded
Exploratory endpoints Any polymorphisms of molecular markers for antimalarial drug resistance and prevalence of HRP2 deletions
Objective To assess the efficacy of both first-line ASAQ and AL for the treatment of uncomplicated P falciparum malaria infections
Study Sites Sacleapea Comprehensive Health Center Saclepea-Mah District in Nimba County and Sinje Health Center Garwula District Sinje in Grand Cape Mount County
Study Period August 2022 to August 2023
Study Design Prospective study of two cohorts with simultaneous enrolment of each therapy
Patient population Patients aged 6 to 59 months with confirmed uncomplicated P falciparum infection
Sample Size Total number of patients to be enrolled is 352 patients This consists of 88 patients per arm per site There are two arms in each of the two sites
Treatments and follow-up Patients enrolled in the ASAQ arm will receive the treatment once daily dose for three days Patients enrolled in the AL arm will receive treatment twice daily dose for three days Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy
Primary endpoints The proportion of patients with early treatment failure late clinical failure late parasitological failure or an adequate clinical and parasitological response as indicators of efficacy Recrudescence will be distinguished from re-infection by polymerase chain reaction PCR analysis
Secondary endpoints The frequency and nature of adverse events will be recorded
Exploratory endpoints Any polymorphisms of molecular markers for antimalarial drug resistance and prevalence of HRP2 deletions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None