Tafenoquine feasibility study in Vietnam
| ISRCTN | ISRCTN15552312 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15552312 |
| Secondary identifying numbers | MMV_TQ_Vietnam_2201 |
- Submission date
- 27/11/2023
- Registration date
- 07/12/2023
- Last edited
- 05/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Malaria is a big health issue in many countries around the world. Among the six types of parasites causing malaria in humans, Plasmodium vivax (P. vivax) is the second most common after P. falciparum, and it's found in the widest range of places. According to the World Health Organization (WHO), there were about 6.4 million cases of P. vivax malaria globally in 2019. P. vivax infection is marked by the persistence of dormant parasites (called liver-stage hypnozoites), leading to recurring malaria episodes months or even years after the first infection.
This study is looking into the practicality of a new way of treating P. vivax malaria. The main goal is to see if this new approach works well in practice, and the secondary goals are to check if it's safe, acceptable, and cost-effective. The new treatment plan includes using a quick test for G6PD and a radical cure treatment with tafenoquine (TQ). The study will roll out this updated plan in health facilities across six districts and also test it in different strategies for finding cases: actively looking for cases, reacting when cases are found, and just waiting for people to come in for treatment. The study will compare how well G6PD testing and TQ work in these different strategies and how much they cost. The evidence collected will be used to inform future decisions. The study will use a mix of methods, including looking at the numbers from case management, talking to people through interviews and group discussions, and comparing costs between the different case-finding approaches.
To make sure the new approach is safe, the study will keep track of patients and deal with any cases of serious side effects. The people involved in the study include those with P. vivax malaria, the healthcare workers treating them, and the staff in charge of malaria programs who actively look for cases.
Who can participate?
Patient with a confirmed P. vivax infection, aged 6 months or older.
What does the study involve?
Patients will be routinely treated according to the national treatment guidelines.
What are the possible benefits and risks of participating?
None
Where is the study run from?
PATH (Switzerland)
When is the study starting and how long is it expected to run for?
June 2023 to December 2025
Who is funding the study?
Bill and Melinda Gates Foundation (USA)
Unitaid (Switzerland)
Who is the main contact?
Dr Thang Tran, thangtran@path.org
Prof Phuc Bui, phucnimpe@gmail.com
Contact information
Public, Scientific, Principal Investigator
34 Trung Van street, Nam Tu Liem district
Ha Noi
100000
Viet Nam
| Phone | +84 983522874 |
|---|---|
| phucnimpe@gmail.com |
Scientific
11th floor, 49 Hai Ba Trung Steet, Tran Hung Dao Ward, Hoan Kiem District
Ha Noi
100000
Viet Nam
| Phone | +84 913301883 |
|---|---|
| thangtran@path.org |
Study information
| Study design | Prospective longitudinal operational study with mixed-methods approach including qualitative component quantitative component and costing component |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital, Medical and other records, Other |
| Study type | Diagnostic, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | 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 |
| Study objectives | The use of tafenoquine after semi-quantitative G6PD testing for radical cure of Plasmodium vivax malaria is operationally feasible based on the revised algorithm in Vietnam, a country approaching elimination. |
| Ethics approval(s) |
1. Approved 25/10/2023, Ethics Review Committee of National Institute of Malariology, Parasitology and Entomology (NIMPE) (34 Trung Van street, Nam Tu Liem district, Ha Noi, 100000, Viet Nam; +84 912216817; thieunq@gmail.com), ref: 407/QD-VSR 2. Approved 13/03/2024, Ethics Review Committee of World Health Organization (Avenue Appia 20 1211 Geneva Switzerland, Geneva, 1201, Switzerland; +41 22 791 21 1; evansr@unitaid.who.int), ref: ERC.0003965 |
| Health condition(s) or problem(s) studied | Malaria plasmodium vivax |
| Intervention | 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 indication. |
| Intervention type | Mixed |
| Primary outcome measure | 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 outcome measures | 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. |
| Overall study start date | 08/06/2023 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient, Health professional, Carer |
|---|---|
| Age group | Mixed |
| Lower age limit | 6 Months |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | 1. Patient with a confirmed P. vivax infection. 2. Patients providing informed consent or assent |
| Key exclusion criteria | 1. Unwilling to provide informed consent 2. Showing signs of severe infection (patients) |
| Date of first enrolment | 15/04/2025 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Viet Nam
Study participating centre
Ha Noi
100000
Viet Nam
Sponsor information
Charity
11th floor, 49 Hai Ba Trung street, Tran Hung Dao ward, Hoan Kiem district
Ha Noi
100000
Viet Nam
| Phone | +84 913301883 |
|---|---|
| info@path.org | |
| Website | https://www.path.org |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
No information available
Results and Publications
| Intention to publish date | 15/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The publications will be submitted to peer review journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
05/03/2025: The following changes were made to the study record:
1. The recruitment start date was changed from 01/03/2025 to 15/04/2025.
2. The recruitment end date was changed from 30/09/2025 to 30/11/2025.
27/01/2025: The recruitment start date was changed from 15/01/2025 to 01/03/2025.
06/11/2024: The following changes were made:
1. The overall study end date was changed from 30/09/2025 to 31/12/2025.
2. The recruitment start date was changed from 15/11/2024 to 15/01/2025.
06/08/2024: The recruitment start date was changed from 15/08/2024 to 15/11/2024.
10/05/2024: The following changes have been made:
1. Ethics Review Committee of World Health Organization approval date added.
2. Public title was changed from "Tafenoquine for malaria feasibility study in Vietnam" to "Tafenoquine feasibility study in Vietnam".
3. The overall study end date was changed from 30/06/2025 to 30/09/2025.
4. The recruitment start date was changed from 15/05/2024 to 15/08/2024.
5. The recruitment end date was changed from 30/06/2024 to 30/09/2025.
06/12/2023: Trial's existence confirmed by Ethics Review Committee of National Institute of Malariology, Parasitology and Entomology (NIMPE).
