Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-08 @ 2:36 AM
Study NCT ID:
NCT03217851
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2017-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence Survey of Antimalarial Drug Resistance Markers
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
Prevalence Survey of Plasmodium Falciparum Antimalarial Drug Resistance Markers in Greater Mekong Subregion
Status:
COMPLETED
Status Verified Date:
2022-05
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:
Study is cross-sectional and observational with one-time dried-blood spot sample collection from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or monoinfection). Samples will be analysed for the presence of molecular markers of resistance to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene amplifications of pfpm2, and additional mutations which may be identified during the course of the trial) in the first instance. Testing to detect additional markers of antimalarial drug resistance will also be performed where feasible. Prevalence of mutations will be summarized and mapped to provide intelligence on antimalarial drug resistance in the region of interest.
Detailed Description:
Malaria Malaria is caused by a mosquito-borne, protozoan parasite belonging to the genus Plasmodium. Of the five species of Plasmodium that infect humans, Plasmodium falciparum is the most deadly and is responsible for the majority of malaria disease and death. Every year, falciparum malaria causes disease in hundreds of millions of people living in the tropics and subtropics, killing a million or more according to some estimates. The vast majority of these deaths occur in sub-Saharan Africa, mostly among young children and infants. When treated with effective antimalarial drugs, malaria can be cured completely.
Antimalarial drug resistance The emergence in Southeast Asia and the subsequent global spread of drug resistant malaria was a major factor contributing to the failure of the first global malaria eradication campaign in the mid-20th century (1). The widespread implementation of highly effective artemisinin-based combination therapy (ACT) for malaria has contributed to significant gains in global control and elimination efforts and has brought malaria eradication back on the agenda, 40 years after the first global malaria eradication campaign was abandoned (2). However the gains seen in the past decade are now at risk as parasite resistance to artemisinin compounds has been confirmed in Southeast Asia and threatens Africa once again (3-8). In the absence of effective vaccines, it is critical to prolong the usable life of antimalarial drugs by judicious implementation of treatment strategies.
Primary Objective To measure prevalence of established and candidate molecular markers of drug resistant malaria in Greater Mekong Subregion
Secondary Objective To map the geographical and temporal changes in prevalence of molecular markers of antimalarial drug resistance in Greater Mekong Subregion
Funder: EXPERTISE FRANCE Grant reference number: Expertise France reference 15SANIN211
Antimalarial drug resistance The emergence in Southeast Asia and the subsequent global spread of drug resistant malaria was a major factor contributing to the failure of the first global malaria eradication campaign in the mid-20th century (1). The widespread implementation of highly effective artemisinin-based combination therapy (ACT) for malaria has contributed to significant gains in global control and elimination efforts and has brought malaria eradication back on the agenda, 40 years after the first global malaria eradication campaign was abandoned (2). However the gains seen in the past decade are now at risk as parasite resistance to artemisinin compounds has been confirmed in Southeast Asia and threatens Africa once again (3-8). In the absence of effective vaccines, it is critical to prolong the usable life of antimalarial drugs by judicious implementation of treatment strategies.
Primary Objective To measure prevalence of established and candidate molecular markers of drug resistant malaria in Greater Mekong Subregion
Secondary Objective To map the geographical and temporal changes in prevalence of molecular markers of antimalarial drug resistance in Greater Mekong Subregion
Funder: EXPERTISE FRANCE Grant reference number: Expertise France reference 15SANIN211
Study Oversight
Has Oversight DMC:
False
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?: