Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575647
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Vivax Elimination With Tafenoquine VET Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Mass Drug Administration of Tafenoquine for P Vivax Radical Cure Safety and Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VET
Brief Summary:
Theoretically so long as there is a sink-source for malaria transmission could be sustained at very low level even at sub-microscopic oscillation and reintroduce malaria either as sporadic cases or as resurgent outbreak Uncertainty or shortage in financing has typically limited the malaria control or elimination projects to go further beyond the Pre-elimination phase Since malaria is no longer a top scoring mortality in national statistics in South East Asia the governmentsstakeholders are less willing to allocate from the austerity budget There are proven evidence of resurgences after cessation of intervention programs where over 90 of all resurgence events were attributed to the interruption of malaria control programmes In Karen state Myanmar-Thailand border multiple factors including a cascade of political financial and logistical fiascos have compounded on the ongoing malaria elimination activities Deleterious impacts after military coup since 2021 February including cessation of foreign investment humanitarian aids Civil Dis-obedience Movement of government staff and resuming armed-conflicts have strained the nearly failed health infrastructure of the country to a collapse stage Interruption of the National Malaria Control activities due to the health system failure and accelerating combats countrywide could inevitably lead to the overturn in recently achieved malaria pre-elimination status especially in Karen state
The disruption in health services within Myanmar is already resulting in an increase in malaria Supply of the first line antimalarial drug artemether-lumefantrine and other essential malaria control interventions has been interrupted The study is proposed to evaluate the impact of Mass Drug Administration MDA in 3 villages in Karen state with consistently high incidence of P vivax and spatially clustered within 5 km radius This proposal outlines a study to assess the feasibility and the safety of tafenoquine MDA
The disruption in health services within Myanmar is already resulting in an increase in malaria Supply of the first line antimalarial drug artemether-lumefantrine and other essential malaria control interventions has been interrupted The study is proposed to evaluate the impact of Mass Drug Administration MDA in 3 villages in Karen state with consistently high incidence of P vivax and spatially clustered within 5 km radius This proposal outlines a study to assess the feasibility and the safety of tafenoquine MDA
Detailed Description:
Malaria remains a major health concern in Myanmar particularly in Karen State along the Myanmar-Thailand border where disruptions in health services have led to a significant increase in cases To address this a study is proposed to assess the feasibility and safety of Mass Drug Administration MDA using tafenoquine a single-dose treatment for P vivax malaria which has been approved in several countries including Thailand The study will focus on three high-incidence villages in Karen State Myanmar with a total population of around 1000
In this study the entire village population will be screened for malaria using Rapid Diagnostic Tests RDT and PCR a highly sensitive method that detects parasites by copying and identifying their unique genetic material in blood samples Participants who test positive for malaria by RDT will receive standard treatment Additionally all participants will be screened for their G6PD enzyme status and will receive tafenoquine if G6PD levels are above 60 units or chloroquine prophylaxis if their enzyme levels are lower or if they are pregnant Impact of MDA on reduction in malaria incidence by RDT and prevalence by PCR will also be evaluated as a secondary outcome of the study
Participation is voluntary and participants can withdraw at any time They will receive full information about the studys risks and benefits before deciding whether to participate
Risks
According to previous research conducted both in this context and in other regions tafenoquine and chloroquine are generally safe with side effects usually being mild The most common side effects are nausea and mild to moderate abdominal pain A research team led by a medical doctor will be on hand to manage any side effects and a referral system will be established in case of any serious adverse events
Benefits
If successful the study could significantly reduce malaria cases in these villages Additionally it could provide valuable insights for implementing Tafenoquine MDA on a larger scale
In this study the entire village population will be screened for malaria using Rapid Diagnostic Tests RDT and PCR a highly sensitive method that detects parasites by copying and identifying their unique genetic material in blood samples Participants who test positive for malaria by RDT will receive standard treatment Additionally all participants will be screened for their G6PD enzyme status and will receive tafenoquine if G6PD levels are above 60 units or chloroquine prophylaxis if their enzyme levels are lower or if they are pregnant Impact of MDA on reduction in malaria incidence by RDT and prevalence by PCR will also be evaluated as a secondary outcome of the study
Participation is voluntary and participants can withdraw at any time They will receive full information about the studys risks and benefits before deciding whether to participate
Risks
According to previous research conducted both in this context and in other regions tafenoquine and chloroquine are generally safe with side effects usually being mild The most common side effects are nausea and mild to moderate abdominal pain A research team led by a medical doctor will be on hand to manage any side effects and a referral system will be established in case of any serious adverse events
Benefits
If successful the study could significantly reduce malaria cases in these villages Additionally it could provide valuable insights for implementing Tafenoquine MDA on a larger scale
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