Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05753150
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-02-21
Brief Title:
Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure After G6PD Testing in Thailand
Sponsor:
Dr Prayuth Sudathip
Organization:
Ministry of Health Thailand
Study Overview
Official Title:
Operational Feasibility of Appropriate Plasmodium Vivax Radical Cure With Tafenoquine or Primaquine After Quantitative G6PD Testing in Thailand
Status:
COMPLETED
Status Verified Date:
2023-10
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:
ARCTIC
Brief Summary:
The purpose of this prospective observational study is to assess the operational feasibility of appropriate radical cure treatment for P vivax malaria with tafenoquine or primaquine in patients 16 year and older after G6PD testing in Thailand The study will be implemented in a phased manner in the provinces of Yala and Mae Hong Son The first phase will be at higher level health facilities hospitals An interim analysis will be conducted after 40 patients are enrolled in the study in order to decide whether the study could be extended to lower level HFs If approved by the Independent Study Oversight Committee the study will be implemented in lower level HFs malaria clinicsHigher level HFs will continue to include patients in the study during this 2nd phaseWritten informed consent assent is required from all patients guardians in the case of minors
Detailed Description:
This is a prospective observational multi-center longitudinal study to be conducted in Yala province and Mae Hong Son province in patients with P vivax malaria
Since 2020 quantitative G6PD testing has been available for routine use prior to providing PQ radical therapy at district hospitals and malaria clinics in the study provinces in line with the national guidelines
Before study start the relevant staff at all participating sites will be re-trained on the quantitative G6PD test procedure and the radical cure treatment algorithm by the Division of Vector Borne Diseases DVBD Standard operating procedures SOP for identification of patients with suspected AHA and guidance for initial management and transfer to a referral hospital will be provided
G6PD tests and TQ will be supplied to Health Facilities HFs by the DVBD using the usual supply route for drugs and diagnostics PQ and other anti-malarial drugs are already available in Thailand
Within the study period investigators will prospectively enroll all patients meeting the selection criteria
Each patient will have to sign an Informed Consent Form ICF indicating their consent for participation in the study by being considered for treatment with TQ provided that they have the appropriate G6PD enzyme activity or treated with PQ according to the current practice otherwise and permitting investigators to use their unidentified data for analysis purposes Assent from patients 18 years of age and the parents or legal guardians written informed consent must be obtained
This study will not change the patientphysician relationship nor influence the investigators drug prescription or therapeutic management of the patient other than what is specified regarding the algorithm for radical cure treatment of P vivax malaria with TQ and PQ
As part of local practice in Yala province and Mae Hong Son province patients treated for P vivax infection are asked to return for a follow-up visit on Day 5 - 1 day This is in addition to the national policy of the first scheduled follow-up visit on Day 14 2- 1 day for vivax malaria patients Patient data will be collected by the investigators on each patient visit
Any suspected case of AHA will be transferred to Yala Referral Hospital the regional hospital with one board-certified haematologist or to the Mae Hong Son Provincial Hospital Both hospitals have full services of blood transfusion renal dialysis and other life-saving procedures for further investigation and treatment
As some patients may not return for the follow-up visits and might develop drug-induced AHA the study staff at the referral hospitals will regularly screen hospital admission records for malaria patients participating in the study presenting signs of AHA diagnosed with renal failure andor receiving blood transfusion
The study will be conducted in 2 phases
1st phase for about 3 months the study will be implemented in higher level HFs hospitals An interim analysis will be conducted after 40 patients 16 years old with P vivax are enrolled in the study in order to decide whether the study could be extended to lower level HFs The decision will be made by an Independent Study Oversight Committee ISOC
2nd phase approximately 2 months if approved by the ISOC the study will be implemented in lower level HFs malaria clinics
Higher level HFs will continue to include patients in the study during this 2nd phase
Final results will be reviewed by the ISOC It is anticipated that it will take a total of about 11-12 months to complete data collection at the target hospitals and malaria clinics
Since 2020 quantitative G6PD testing has been available for routine use prior to providing PQ radical therapy at district hospitals and malaria clinics in the study provinces in line with the national guidelines
Before study start the relevant staff at all participating sites will be re-trained on the quantitative G6PD test procedure and the radical cure treatment algorithm by the Division of Vector Borne Diseases DVBD Standard operating procedures SOP for identification of patients with suspected AHA and guidance for initial management and transfer to a referral hospital will be provided
G6PD tests and TQ will be supplied to Health Facilities HFs by the DVBD using the usual supply route for drugs and diagnostics PQ and other anti-malarial drugs are already available in Thailand
Within the study period investigators will prospectively enroll all patients meeting the selection criteria
Each patient will have to sign an Informed Consent Form ICF indicating their consent for participation in the study by being considered for treatment with TQ provided that they have the appropriate G6PD enzyme activity or treated with PQ according to the current practice otherwise and permitting investigators to use their unidentified data for analysis purposes Assent from patients 18 years of age and the parents or legal guardians written informed consent must be obtained
This study will not change the patientphysician relationship nor influence the investigators drug prescription or therapeutic management of the patient other than what is specified regarding the algorithm for radical cure treatment of P vivax malaria with TQ and PQ
As part of local practice in Yala province and Mae Hong Son province patients treated for P vivax infection are asked to return for a follow-up visit on Day 5 - 1 day This is in addition to the national policy of the first scheduled follow-up visit on Day 14 2- 1 day for vivax malaria patients Patient data will be collected by the investigators on each patient visit
Any suspected case of AHA will be transferred to Yala Referral Hospital the regional hospital with one board-certified haematologist or to the Mae Hong Son Provincial Hospital Both hospitals have full services of blood transfusion renal dialysis and other life-saving procedures for further investigation and treatment
As some patients may not return for the follow-up visits and might develop drug-induced AHA the study staff at the referral hospitals will regularly screen hospital admission records for malaria patients participating in the study presenting signs of AHA diagnosed with renal failure andor receiving blood transfusion
The study will be conducted in 2 phases
1st phase for about 3 months the study will be implemented in higher level HFs hospitals An interim analysis will be conducted after 40 patients 16 years old with P vivax are enrolled in the study in order to decide whether the study could be extended to lower level HFs The decision will be made by an Independent Study Oversight Committee ISOC
2nd phase approximately 2 months if approved by the ISOC the study will be implemented in lower level HFs malaria clinics
Higher level HFs will continue to include patients in the study during this 2nd phase
Final results will be reviewed by the ISOC It is anticipated that it will take a total of about 11-12 months to complete data collection at the target hospitals and malaria clinics
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