Operational Feasibility of Appropriate Radical Cure of Plasmodium Vivax With Tafenoquine or Primaquine After Quantitative G6PD Testing in Brazil
Trust
1 other identifier
observational
16,000
1 country
41
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2021
CompletedFirst Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
October 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2023
CompletedJune 13, 2023
June 1, 2023
12 months
September 27, 2021
June 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of P. vivax patients ≥16 years of age treated or not with TQ according to the appropriate level of G6PD enzyme activity.
After the inclusion of 600 patients, approximately 15 months after study start.
Secondary Outcomes (4)
Percentage of patients with P. vivax ≥6 months treated or not with PQ according to the appropriate level of G6PD enzyme activity
15 months after study start
Description of the characteristics of patients treated with TQ or PQ
15 months after study start
Frequency of drug-induced acute hemolytic anemia (AHA)
15 months after study start
Hospitalization due to confirmed drug-induced AHA
15 months after study start
Study Arms (3)
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.
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.
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.
Interventions
Daily primaquine adjusted by weight (0.5 mg/kg/day for 7 days)
Eligibility Criteria
The study will be carried out in Brazil, in the municipalities of Manaus (state of Amazonas) and Porto Velho (state of Rondônia).Relevant staff members at health facilities will be trained by RP staff and municipal authorities using educational material on the need and use of G6PD testing, treatment algorithm based on G6PD activity levels, TQ adverse events and PQ, identifying, reporting and managing adverse events to ANVISA and MS (completion of the SIVEP DEMO form).
You may qualify if:
- Diagnosis of P. vivax malaria (parasitologically confirmed by microscopy or rapid diagnostic test) over six months of age.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundação de Medicina Tropical Dr. Heitor Vieira Douradolead
- Centro de Pesquisa em Medicina Tropicalcollaborator
- Medicines for Malaria Venturecollaborator
- Ministry of Health, Brazilcollaborator
- Secretária Municipal de Saúde de Manauscollaborator
- Secretária Estadual de Saúde do Amazonascollaborator
Study Sites (41)
Fundação de Medicina Tropical Dr Heitor Vieira Dourado
Manaus, Amazonas, 69040000, 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, 69055010, Brazil
Upa Campos Sales
Manaus, Brazil
UPA Danilo Corrêa
Manaus, Brazil
UPA José Rodrigues
Manaus, Brazil
Policlínica Ana Adelaide
Rondônia, Brazil
Related Publications (2)
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.
PMID: 38452779DERIVEDBrito 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.
PMID: 38365417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcus Lacerda, MD, PhD
Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- PRINCIPAL INVESTIGATOR
Dhelio Batista, MD, PhD
Centro de Pesquisa em Medicina Tropical (CEPEM)
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
October 27, 2021
Study Start
September 9, 2021
Primary Completion
August 30, 2022
Study Completion
September 9, 2023
Last Updated
June 13, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share