Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347471
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-03-29
Brief Title:
The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy
Sponsor:
Infectious Diseases Research Collaboration Uganda
Organization:
Infectious Diseases Research Collaboration Uganda
Study Overview
Official Title:
The Transmission of Artemisinin Resistant Parasites Before and After Conventional Artemisinin-combination Therapy a Longitudinal Study
Status:
RECRUITING
Status Verified Date:
2024-03
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:
SPARTAN
Brief Summary:
A prospective study will be carried out in an area where parasites with reduced sensitivity to malaria drugs artemisinins have recently emerged The study will recruit participants from patients who attend the clinic with uncomplicated malaria and are treated with conventional artemisinin-combination therapies ACT as part of standard clinical care From this population we will select P falciparum gametocyte carriers
Before during and after ACT treatment the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy molecular methods parasite culture and mosquito feeding assays Parasite clearance will be determined in the first days d0-3 after treatment
The study population will consist of passively recruited patients with uncomplicated P falciparum malaria who are microscopy positive for gametocytes Participants will be treated with conventional therapies for uncomplicated malaria without randomization artemether-lumefantrine AL or dihydroartemisinin-piperaquine DHA-PPQ All doses are supervised Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment
Gametocyte carriage and gametocyte commitmentproduction will be determined for resistant and wild type infections before during and after treatment In addition venous blood will be collected at three timepoints to assess transmission to mosquitoes before d0 during d2 and after treatment d7 The total duration of participation will be 7 days the primary endpoint will be the reduction in mosquito infection rates at d2 artemether-lumefantrine or d7 dihydroartemisinin-piperaquine compared to pre-treatment
Before during and after ACT treatment the transmission potential of artemisinin resistant and wild type infections will be assessed by microscopy molecular methods parasite culture and mosquito feeding assays Parasite clearance will be determined in the first days d0-3 after treatment
The study population will consist of passively recruited patients with uncomplicated P falciparum malaria who are microscopy positive for gametocytes Participants will be treated with conventional therapies for uncomplicated malaria without randomization artemether-lumefantrine AL or dihydroartemisinin-piperaquine DHA-PPQ All doses are supervised Parasite clearance is assessed ex vivo by ring-stage survival assays and by daily slides during the first days of treatment
Gametocyte carriage and gametocyte commitmentproduction will be determined for resistant and wild type infections before during and after treatment In addition venous blood will be collected at three timepoints to assess transmission to mosquitoes before d0 during d2 and after treatment d7 The total duration of participation will be 7 days the primary endpoint will be the reduction in mosquito infection rates at d2 artemether-lumefantrine or d7 dihydroartemisinin-piperaquine compared to pre-treatment
Detailed Description:
None
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