Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
NCT ID: NCT05096702
Last Updated: 2023-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
16000 participants
OBSERVATIONAL
2021-09-09
2023-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Radical Cure (RC) With Tafenoquine or Primaquine After Semi-quantitative G6PD Testing: A Feasibility Study in Peru
NCT05361486
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
NCT06148792
Short Course Primaquine for the Radical Cure of P. Vivax Malaria - Indonesia
NCT05879224
Short Course Primaquine for the Radical Cure of P. Vivax - Papua New Guinea
NCT05874271
Study to Evaluate the Efficacy and Safety of Tafenoquine for the Treatment of Plasmodium Vivax in Adults
NCT01290601
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Tafenoquine (TQ)
Patients aged ≥16 years, G6PD activity ≥ 6.1 IU/gHb, not pregnant or breastfeeding, will receive single-dose TQ in addition to standard blood schizonticidal drug.
Tafenoquine
Tafenoquine 300 mg (2x150mg tablets)
Daily primaquine (PQ) for 7 days
Patients aged ≥ 6 months, with G6PD activity between 4.1 and 6.0 IU/gHb, not pregnant or breastfeeding for \< 1 month, will receive daily PQ in addition to standard blood schizonticidal drug.
Primaquine
Daily primaquine adjusted by weight (0.5 mg/kg/day for 7 days)
Weekly primaquine for 8 weeks
Patients aged ≥ 6 months, with G6PD activity ≤ 4.0 IU/gHb, not pregnant or breastfeeding for \< 1 month, will receive weekly once-a-week PQ for eight weeks in addition to standard blood schizonticidal drug.
Primaquine
Weekly primaquine adjusted by weight (0.75mg/kg/week for 8 weeks)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Tafenoquine
Tafenoquine 300 mg (2x150mg tablets)
Primaquine
Daily primaquine adjusted by weight (0.5 mg/kg/day for 7 days)
Primaquine
Weekly primaquine adjusted by weight (0.75mg/kg/week for 8 weeks)
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centro de Pesquisa em Medicina Tropical
UNKNOWN
Medicines for Malaria Venture
OTHER
Ministry of Health, Brazil
OTHER_GOV
Secretária Municipal de Saúde de Manaus
UNKNOWN
Secretária Estadual de Saúde do Amazonas
UNKNOWN
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcus Lacerda, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
Dhelio Batista, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centro de Pesquisa em Medicina Tropical (CEPEM)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fundação de Medicina Tropical Dr Heitor Vieira Dourado
Manaus, Amazonas, Brazil
Bela Vista
Manaus, Amazonas, Brazil
Campos Salles (Base)
Manaus, Amazonas, Brazil
Colônia Antônio Aleixo
Manaus, Amazonas, Brazil
Cooperativa I
Manaus, Amazonas, Brazil
Cueiras (UBSR)
Manaus, Amazonas, Brazil
Efigênio Salles (UBSR)
Manaus, Amazonas, Brazil
Grande Vitória
Manaus, Amazonas, Brazil
João Paulo II
Manaus, Amazonas, Brazil
Pau Rosa (UBSR)
Manaus, Amazonas, Brazil
Platão Araújo (Base)
Manaus, Amazonas, Brazil
Santa Inês
Manaus, Amazonas, Brazil
São Pedro (UBSR)
Manaus, Amazonas, Brazil
União da Vitória
Manaus, Amazonas, Brazil
Centro de Pesquisa em Medicina Tropical (Cepem)
Porto Velho, Rondônia, Brazil
UBS Abunã
Porto Velho, Rondônia, Brazil
UBS Agrovila
Porto Velho, Rondônia, Brazil
UBS Calama
Porto Velho, Rondônia, Brazil
UBS Calderita
Porto Velho, Rondônia, Brazil
UBS Cujubim
Porto Velho, Rondônia, Brazil
UBS Extrema
Porto Velho, Rondônia, Brazil
UBS Fortaleza do Abunã
Porto Velho, Rondônia, Brazil
UBS Jacy-Paraná
Porto Velho, Rondônia, Brazil
UBS José Adelino
Porto Velho, Rondônia, Brazil
UBS Nazaré
Porto Velho, Rondônia, Brazil
UBS Nova Califórnia
Porto Velho, Rondônia, Brazil
UBS Nova Mutum
Porto Velho, Rondônia, Brazil
UBS Palmares
Porto Velho, Rondônia, Brazil
UBS Rio das Garças
Porto Velho, Rondônia, Brazil
UBS Rio Pardo
Porto Velho, Rondônia, Brazil
UBS Ronaldo Aragão
Porto Velho, Rondônia, Brazil
UBS São Carlos
Porto Velho, Rondônia, Brazil
UBS União Bandeirantes
Porto Velho, Rondônia, Brazil
UBS Vila DNIT
Porto Velho, Rondônia, Brazil
UBS Vista Alegre
Porto Velho, Rondônia, Brazil
Upa Zona Leste
Porto Velho, Rondônia, Brazil
SPA Hospital Chapot Prevost
Manaus, , Brazil
Upa Campos Sales
Manaus, , Brazil
UPA Danilo Corrêa
Manaus, , Brazil
UPA José Rodrigues
Manaus, , Brazil
Policlínica Ana Adelaide
Rondônia, , Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Brito M, Rufatto R, Brito-Sousa JD, Murta F, Sampaio V, Balieiro P, Baia-Silva D, Castro V, Alves B, Alencar A, Duparc S, Grewal Daumerie P, Borghini-Fuhrer I, Jambert E, Peterka C, Edilson Lima F Jr, Carvalho Maia L, Lucena Cruz C, Maciele B, Vasconcelos M, Machado M, Augusto Figueira E, Alcirley Balieiro A, Batista Pereira D, Lacerda M. Operational effectiveness of tafenoquine and primaquine for the prevention of Plasmodium vivax recurrence in Brazil: a retrospective observational study. Lancet Infect Dis. 2024 Jun;24(6):629-638. doi: 10.1016/S1473-3099(24)00074-4. Epub 2024 Mar 4.
Brito M, Rufatto R, Murta F, Sampaio V, Balieiro P, Baia-Silva D, Castro V, Alves B, Alencar A, Duparc S, Grewal Daumerie P, Borghini-Fuhrer I, Jambert E, Peterka C, Edilson Lima F Jr, Carvalho Maia L, Lucena Cruz C, Maciele B, Vasconcelos M, Machado M, Augusto Figueira E, Alcirley Balieiro A, Menezes A, Ataides R, Batista Pereira D, Lacerda M. Operational feasibility of Plasmodium vivax radical cure with tafenoquine or primaquine following point-of-care, quantitative glucose-6-phosphate dehydrogenase testing in the Brazilian Amazon: a real-life retrospective analysis. Lancet Glob Health. 2024 Mar;12(3):e467-e477. doi: 10.1016/S2214-109X(23)00542-9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAAE: 16867319.6.0000.0008
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.