Ignite Creation Date:
2024-05-06 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 2:16 PM
Study NCT ID:
NCT05096702
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-13
First Post:
2021-09-27
Brief Title:
Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
Sponsor:
Fundação de Medicina Tropical Dr Heitor Vieira Dourado
Organization:
Fundação de Medicina Tropical Dr Heitor Vieira Dourado
Study Overview
Official Title:
Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
Trust
Brief Summary:
This is an observational study carried out in Brazil in patients with P vivax malaria The study will be carried out in the municipalities of Manaus state of Amazonas and Porto Velho state of Rondônia
G6PD and TQ tests will be provided to health facilities by municipal health authorities using the common route for the provision of drugs and diagnostics PQ and other antimalarial drugs are already available in Brazil
Designated personnel at the health facilities will be trained to perform the G6PD quantitative test procedure and the radical healing treatment algorithm by the Lead Researcher RP team and municipal authorities using teaching materials developed by the sponsors
The study design is based on the secondary use of data routinely collected from all malaria patients in the Epidemiological Surveillance Information System for Malaria SIVEP-Malaria by the Ministry of Health MS Data from all malaria patients are routinely collected through SIVEP forms by health professionals HP and entered into the SIVEP database by the municipality staff
The SIVEP form will be adapted by the MS to collect information about the G6PD test TQ treatment and signs of hemolysis The retrospective data from all patients will be entered into a new database by the municipality staff during the study period and the relevant data will be automatically exported weekly to the SIVEP database The study team will only have access to unidentified data according to the access levels that will be assigned to each member in the system Only the municipalitys team will have access to the identified patient data In addition to the data collected on the SIVEP forms the PR team will ask the two referral hospitals that routinely receive all admissions due to AHA to perform a regular screening of electronic hospital admission records for patients with signs of AHA renal failure jaundice blood transfusion malaria All identified cases will be investigated using hospital records and SIVEP forms Confirmed information about drug-induced AHA will be linked to the patient record recorded in the database The PR team will also contribute to pharmacovigilance training Physicians at tertiary-level health units will report side effects through the VigiMed system from the National Health Surveillance Agency ANVISAFinally the additional costs of implementing the G6PD and TQ tests will be collected along with the study at the health facilities
Since the study is based on retrospective data collection and the adoption of TQ and G6PD testing will be done by the municipality the G6PD testing and the treatment of patients with TQ or PQ will be carried out in accordance with the treatment policy that is regardless of the study
The study will be carried out in phases
- 1st phase approximately 3 months Training and provision of G6PD and TQ tests will initially be limited to 10 high-complexity and intermediate-complexity units referral hospitals hospitals emergency care units polyclinics Data will be collected from patients with P vivax treated at these health facilities
An interim analysis will be performed after collecting data from 600 patients with P vivax 16 years who have not been treated for vivax malaria in the past 60 days in the study database in order to decide whether the study can be extended to less complex health units The decision will be made by an Independent Study Oversight Committee ISOC
If the interim results of Phase 1 are found to be unsatisfactory ISOC may decide not to extend the study to primary care units until improvements in the educational program are implemented andor additional support is provided to health professionals Additional interim analyzes will be performed as appropriate
- 2nd phase approximately 9 months CURRENT PHASE if approved by ISOC the study will be extended to less complex health units basic health units family health units and other primary care services and other high and medium complexity of health in the selected municipalities After staff training G6PD and TQ testing will be provided to these health facilities by municipal health authorities
During this 2nd phase data will continue to be collected from patients with P vivax treated by the 1st phase tertiary care units
- An additional interim analysis will be performed after data from 600 patients with P vivax 16 years old who have not been treated for P vivax malaria in the past 60 days from primary care units are collected in the study database approximately 3 months after the start of the 2nd phase
The study will continue while the interim analyzes are being carried out Final results will be analyzed and validated by ISOC The study is expected to take approximately 15 months
G6PD and TQ tests will be provided to health facilities by municipal health authorities using the common route for the provision of drugs and diagnostics PQ and other antimalarial drugs are already available in Brazil
Designated personnel at the health facilities will be trained to perform the G6PD quantitative test procedure and the radical healing treatment algorithm by the Lead Researcher RP team and municipal authorities using teaching materials developed by the sponsors
The study design is based on the secondary use of data routinely collected from all malaria patients in the Epidemiological Surveillance Information System for Malaria SIVEP-Malaria by the Ministry of Health MS Data from all malaria patients are routinely collected through SIVEP forms by health professionals HP and entered into the SIVEP database by the municipality staff
The SIVEP form will be adapted by the MS to collect information about the G6PD test TQ treatment and signs of hemolysis The retrospective data from all patients will be entered into a new database by the municipality staff during the study period and the relevant data will be automatically exported weekly to the SIVEP database The study team will only have access to unidentified data according to the access levels that will be assigned to each member in the system Only the municipalitys team will have access to the identified patient data In addition to the data collected on the SIVEP forms the PR team will ask the two referral hospitals that routinely receive all admissions due to AHA to perform a regular screening of electronic hospital admission records for patients with signs of AHA renal failure jaundice blood transfusion malaria All identified cases will be investigated using hospital records and SIVEP forms Confirmed information about drug-induced AHA will be linked to the patient record recorded in the database The PR team will also contribute to pharmacovigilance training Physicians at tertiary-level health units will report side effects through the VigiMed system from the National Health Surveillance Agency ANVISAFinally the additional costs of implementing the G6PD and TQ tests will be collected along with the study at the health facilities
Since the study is based on retrospective data collection and the adoption of TQ and G6PD testing will be done by the municipality the G6PD testing and the treatment of patients with TQ or PQ will be carried out in accordance with the treatment policy that is regardless of the study
The study will be carried out in phases
- 1st phase approximately 3 months Training and provision of G6PD and TQ tests will initially be limited to 10 high-complexity and intermediate-complexity units referral hospitals hospitals emergency care units polyclinics Data will be collected from patients with P vivax treated at these health facilities
An interim analysis will be performed after collecting data from 600 patients with P vivax 16 years who have not been treated for vivax malaria in the past 60 days in the study database in order to decide whether the study can be extended to less complex health units The decision will be made by an Independent Study Oversight Committee ISOC
If the interim results of Phase 1 are found to be unsatisfactory ISOC may decide not to extend the study to primary care units until improvements in the educational program are implemented andor additional support is provided to health professionals Additional interim analyzes will be performed as appropriate
- 2nd phase approximately 9 months CURRENT PHASE if approved by ISOC the study will be extended to less complex health units basic health units family health units and other primary care services and other high and medium complexity of health in the selected municipalities After staff training G6PD and TQ testing will be provided to these health facilities by municipal health authorities
During this 2nd phase data will continue to be collected from patients with P vivax treated by the 1st phase tertiary care units
- An additional interim analysis will be performed after data from 600 patients with P vivax 16 years old who have not been treated for P vivax malaria in the past 60 days from primary care units are collected in the study database approximately 3 months after the start of the 2nd phase
The study will continue while the interim analyzes are being carried out Final results will be analyzed and validated by ISOC The study is expected to take approximately 15 months
Detailed Description:
This is an observational study carried out in Brazil in patients with P vivax malaria The study will be carried out in the municipalities of Manaus state of Amazonas and Porto Velho state of Rondônia
G6PD and TQ tests will be provided to health facilities by municipal health authorities using the common route for the provision of drugs and diagnostics PQ and other antimalarial drugs are already available in Brazil
Designated personnel at the health facilities will be trained to perform the G6PD quantitative test procedure and the radical healing treatment algorithm by the Lead Researcher RP team and municipal authorities using teaching materials developed by the sponsors
The study design is based on the secondary use of data routinely collected from all malaria patients in the Epidemiological Surveillance Information System for Malaria SIVEP-Malaria by the Ministry of Health MS Data from all malaria patients are routinely collected through SIVEP forms by health professionals HP and entered into the SIVEP database by the municipality staff
The SIVEP form will be adapted by the MS to collect information about the G6PD test TQ treatment and signs of hemolysis The retrospective data from all patients will be entered into a new database by the municipality staff during the study period and the relevant data will be automatically exported weekly to the SIVEP database The study team will only have access to unidentified data according to the access levels that will be assigned to each member in the system Only the municipalitys team will have access to the identified patient data In addition to the data collected on the SIVEP forms the PR team will ask the two referral hospitals that routinely receive all admissions due to AHA to perform a regular screening of electronic hospital admission records for patients with signs of AHA renal failure jaundice blood transfusion malaria All identified cases will be investigated using hospital records and SIVEP forms Confirmed information about drug-induced AHA will be linked to the patient record recorded in the database The PR team will also contribute to pharmacovigilance training Physicians at tertiary-level health units will report side effects through the VigiMed system from the National Health Surveillance Agency ANVISAFinally the additional costs of implementing the G6PD and TQ tests will be collected along with the study at the health facilities
Since the study is based on retrospective data collection and the adoption of TQ and G6PD testing will be done by the municipality the G6PD testing and the treatment of patients with TQ or PQ will be carried out in accordance with the treatment policy that is regardless of the study
The study will be carried out in phases
- 1st phase approximately 3 months Training and provision of G6PD and TQ tests will initially be limited to 10 high-complexity and intermediate-complexity units referral hospitals hospitals emergency care units polyclinics Data will be collected from patients with P vivax treated at these health facilities
An interim analysis will be performed after collecting data from 600 patients with P vivax 16 years who have not been treated for vivax malaria in the past 60 days in the study database in order to decide whether the study can be extended to less complex health units The decision will be made by an Independent Study Oversight Committee ISOC
If the interim results of Phase 1 are found to be unsatisfactory ISOC may decide not to extend the study to primary care units until improvements in the educational program are implemented andor additional support is provided to health professionals Additional interim analyzes will be performed as appropriate
- 2nd phase approximately 9 months CURRENT PHASE if approved by ISOC the study will be extended to less complex health units basic health units family health units and other primary care services and other high and medium complexity of health in the selected municipalities After staff training G6PD and TQ testing will be provided to these health facilities by municipal health authorities
During this 2nd phase data will continue to be collected from patients with P vivax treated by the 1st phase tertiary care units
- An additional interim analysis will be performed after data from 600 patients with P vivax 16 years old who have not been treated for P vivax malaria in the past 60 days from primary care units are collected in the study database approximately 3 months after the start of the 2nd phase
The study will continue while the interim analyzes are being carried out Final results will be analyzed and validated by ISOC The study is expected to take approximately 15 months
G6PD and TQ tests will be provided to health facilities by municipal health authorities using the common route for the provision of drugs and diagnostics PQ and other antimalarial drugs are already available in Brazil
Designated personnel at the health facilities will be trained to perform the G6PD quantitative test procedure and the radical healing treatment algorithm by the Lead Researcher RP team and municipal authorities using teaching materials developed by the sponsors
The study design is based on the secondary use of data routinely collected from all malaria patients in the Epidemiological Surveillance Information System for Malaria SIVEP-Malaria by the Ministry of Health MS Data from all malaria patients are routinely collected through SIVEP forms by health professionals HP and entered into the SIVEP database by the municipality staff
The SIVEP form will be adapted by the MS to collect information about the G6PD test TQ treatment and signs of hemolysis The retrospective data from all patients will be entered into a new database by the municipality staff during the study period and the relevant data will be automatically exported weekly to the SIVEP database The study team will only have access to unidentified data according to the access levels that will be assigned to each member in the system Only the municipalitys team will have access to the identified patient data In addition to the data collected on the SIVEP forms the PR team will ask the two referral hospitals that routinely receive all admissions due to AHA to perform a regular screening of electronic hospital admission records for patients with signs of AHA renal failure jaundice blood transfusion malaria All identified cases will be investigated using hospital records and SIVEP forms Confirmed information about drug-induced AHA will be linked to the patient record recorded in the database The PR team will also contribute to pharmacovigilance training Physicians at tertiary-level health units will report side effects through the VigiMed system from the National Health Surveillance Agency ANVISAFinally the additional costs of implementing the G6PD and TQ tests will be collected along with the study at the health facilities
Since the study is based on retrospective data collection and the adoption of TQ and G6PD testing will be done by the municipality the G6PD testing and the treatment of patients with TQ or PQ will be carried out in accordance with the treatment policy that is regardless of the study
The study will be carried out in phases
- 1st phase approximately 3 months Training and provision of G6PD and TQ tests will initially be limited to 10 high-complexity and intermediate-complexity units referral hospitals hospitals emergency care units polyclinics Data will be collected from patients with P vivax treated at these health facilities
An interim analysis will be performed after collecting data from 600 patients with P vivax 16 years who have not been treated for vivax malaria in the past 60 days in the study database in order to decide whether the study can be extended to less complex health units The decision will be made by an Independent Study Oversight Committee ISOC
If the interim results of Phase 1 are found to be unsatisfactory ISOC may decide not to extend the study to primary care units until improvements in the educational program are implemented andor additional support is provided to health professionals Additional interim analyzes will be performed as appropriate
- 2nd phase approximately 9 months CURRENT PHASE if approved by ISOC the study will be extended to less complex health units basic health units family health units and other primary care services and other high and medium complexity of health in the selected municipalities After staff training G6PD and TQ testing will be provided to these health facilities by municipal health authorities
During this 2nd phase data will continue to be collected from patients with P vivax treated by the 1st phase tertiary care units
- An additional interim analysis will be performed after data from 600 patients with P vivax 16 years old who have not been treated for P vivax malaria in the past 60 days from primary care units are collected in the study database approximately 3 months after the start of the 2nd phase
The study will continue while the interim analyzes are being carried out Final results will be analyzed and validated by ISOC The study is expected to take approximately 15 months
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?:
False
Is an FDA AA801 Violation?:
None