Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT05096702 |
| Other study ID # |
CAAE: 16867319.6.0000.0008 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 9, 2021 |
| Est. completion date |
September 9, 2023 |
Study information
| Verified date |
June 2023 |
| Source |
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 municipality's 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
(ANVISA).Finally, 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 and/or 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.
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 municipality's 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
(ANVISA).Finally, 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 and/or 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.
