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Tafenoquine feasibility study in Vietnam

A mixed-method operational research study on the use of tafenoquine and G6PD testing for radical cure of Plasmodium vivax malaria in passive and active case detection in Vietnam

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN15552312
Enrollment
150
Registered
2023-12-07
Start date
2025-08-23
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria plasmodium vivax Infections and Infestations

Interventions

Patients will be routinely treated according to the national treatment guidelines in which tafenoquine has been included, we only obtain the informed consent to collect data for assessment of correct

Sponsors

PATH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 100 Years

Inclusion criteria

Inclusion criteria: 1. Patient with a confirmed P. vivax infection. 2. Patients providing informed consent or assent

Exclusion criteria

Exclusion criteria: 1. Unwilling to provide informed consent 2. Showing signs of severe infection (patients)

Design outcomes

Primary

MeasureTime frame
Measured using patient records at the end of the study: 1. Proportion of P. vivax infected individuals that are correctly treated with TQ based on the revised algorithm as an aggregate and within each of three case finding strategies. 2. Proportion of P. vivax and mixed P. vivax infected individuals that are correctly treated with PQ based on the revised algorithm as an aggregate and within each of three case finding strategies.

Secondary

MeasureTime frame
Measured using patient records at the end of the study: 1. Proportion of non-eligible patients that receive Radical Cure (TQ&PQ) treatment 2. Proportion of patients experiencing acute hemolytic anemia (AHA) during the patient follow-up period 3. Health care provider knowledge and skills regarding G6PD testing and radical cure treatment over time as determined by a competency assessment 4. Patients, health care provider and supervisors’ perceptions of and experience with the new RC tools, specifically TQ, as reported in interviews and focus group discussions 5. Total monetary cost of including G6PD testing and single dose cure compared across case finding strategies 6. Per patient monetary cost of including G6PD testing and single dose cure compared across case finding strategies. 7. Number of recurrences of P.vivax infection reported by study participants during study duration, in total and stratified by treatment type. 8. The number of study participants who present again to the facility or are identified through active case detection methods with a recurrence of P.vivax infection during study duration in total and stratified by treatment type. 9. Number of P. vivax patients reporting moderate, severe, and serious adverse events after TQ and PQ administration during the study conduct. 10. Frequency and severity of each moderate, severe, and serious adverse event reported after TQ and PQ administration during the study conduct.

Countries

Viet Nam

Contacts

Public ContactPhuc Bui
phucnimpe@gmail.com+84 983522874

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026