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Trial registered on ANZCTR


Registration number
ACTRN12622000272796p
Ethics application status
Submitted, not yet approved
Date submitted
6/02/2022
Date registered
14/02/2022
Date last updated
6/10/2022
Date data sharing statement initially provided
14/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of weekly tafenoquine antimalarial prophylaxis in Vietnam People’s Army personnel in South Sudan
Scientific title
Evaluation of the safety, tolerability and effectiveness of weekly tafenoquine for malaria prophylaxis in Vietnam People’s Army personnel in South Sudan
Secondary ID [1] 306356 0
VDCP03 Version 1.0 12 December 2021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malaria 325157 0
Condition category
Condition code
Infection 322562 322562 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tafenoquine tablets will be administered orally, with a loading dose of 200 mg daily for 3 consecutive days followed by weekly (200 mg) dosing for 25 weeks.
Intervention code [1] 322784 0
Prevention
Intervention code [2] 322805 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330356 0
Monitor the safety of weekly tafenoquine in Vietnamese People's Army personnel on peacekeeping duties in South Sudan.
Timepoint [1] 330356 0
Blood sample collected at baseline (screening - before tafenoquine treatment), 3 days after starting the loading dose of tafenoquine and at weeks 4, 8, 16 and 26 (primary endpoint) of the weekly maintenance tafenoquine dose for a full blood count, liver function and urinalysis tests. Also, at these timepoints, the participant's resting pulse (heart rate) will be measured using a heart rate monitor and blood pressure recorded using a pulse oximeter.
Primary outcome [2] 330386 0
Monitor the tolerability of weekly tafenoquine in Vietnamese People's Army personnel on peacekeeping duties in South Sudan.
Timepoint [2] 330386 0
At baseline (screening - before tafenoquine treatment), Day 3 after starting the loading dose of tafenoquine and at weeks 4, 8, 16 and 26 (primary endpoint) of the weekly maintenance tafenoquine dose, a physical examination will be carried out as well as recording participant's responses to a questionnaire of possible adverse reactions (e.g., abdominal pain, nausea, vomiting, headache, and dizziness) to the drug. Adverse reactions will also be recorded by the study doctor after each administration of the loading dose. The adverse reactions questionnaire has been specifically designed for this study. The participants will also record weekly in a diary the time of tafenoquine dosing and adverse reactions that may occur from weeks 1 to 25.
Primary outcome [3] 330388 0
Monitor the effectiveness of weekly tafenoquine in Vietnamese People's Army personnel on peacekeeping duties in South Sudan.
Timepoint [3] 330388 0
Blood sample collected at baseline (screening - before tafenoquine treatment), 3 days after starting the loading dose of tafenoquine and at weeks 4, 8, 16 and 26 (primary endpoint) of the weekly tafenoquine maintenance dose for a rapid diagnostic test, blood film microscopy and polymerase chain reaction test to determine whether the participant is infected with malaria.
Secondary outcome [1] 405933 0
Determine the participants’ pharmacokinetic (PK) of tafenoquine after the loading dose (blood maximum concentration - Cmax) and weekly tafenoquine maintenance dosing (steady-state blood minimum concentration - Cmin) during the study period.
Timepoint [1] 405933 0
Blood sample collected at about 22 hours after the last tafenoquine loading dose (i.e. Day 3 - Cmax) and at weeks 4, 8, 16 and 26 of the weekly tafenoquine maintenance dose (i..e. Cmin).
Secondary outcome [2] 405935 0
Monitor for the presence of submicroscopic asymptomatic malaria in participants on weekly tafenoquine.
Timepoint [2] 405935 0
Blood sample collected at baseline (screening - before tafenoquine treatment) and at weeks 4, 8, 16 and 26 (primary endpoint) of the weekly tafenoquine maintenance dose for polymerase chain reaction (PCR) test to detect for submicroscopic asymptomatic malaria,
Secondary outcome [3] 405936 0
Characterize the Plasmodium speciation in participants who may experience a malaria infection during the intervention study.
Timepoint [3] 405936 0
Blood sample collected at the time of malaria diagnosis for PCR testing to determine malaria speciation.
Secondary outcome [4] 406062 0
Characterize the drug-resistant profile of the malaria parasite population in participants who may experience a malaria infection during the intervention study.
Timepoint [4] 406062 0
Apply validated molecular markers for drug resistance such as polymorphisms of the Pfkelch13 gene and amplification of the Pfmdr1 gene on blood samples collected from participants at the time of malaria diagnosis.

Eligibility
Key inclusion criteria
1) Adults (male and female).
2) Glucose-6-phospate dehydrogenase (G6PD) normal enzyme activity levels (>70%) of the site median value for G6PD normals using a quantitative G6PD test.
3) Willing and able to comply with all monitoring visits, physical examination, adverse events questionnaire, laboratory tests, and other study procedures.
4) Willingness to complete an acceptability questionnaire.
5) Completion of the written informed consent process prior to undertaking any study-related procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) G6PD deficiency.
2) Prior or current history of nervous system and psychiatric disorders.
3) Any participant who is directly involved in conducting the study.
4) Any participant with poor peripheral venous access for blood sampling.
5) Known hypersensitivity reactions to primaquine.
6) Pregnant women.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
No sample size calculation is provided as the number of participants potentially available is limited to 63 individuals. For single arm efficacy studies of antimalarials a representative sample size is 50 malaria patients (World Health Organization. 2009. Methods for Surveillance of Antimalarial Drug Efficacy. Geneva, World Health Organization). For this study, we will aim to recruit 63 volunteers to have a representative population to assess the safety, tolerability and efficacy of weekly tafenoquine.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Unable to obtain in-country Vietnam MoH Institutional Review Boards in National Biomedical Research ethical approval of the protocol prior to departure of potential study participants to South Sudan in May 2022. Attempts to recruit next rotation of health personnel to South Sudan in May 2023 was unsuccessful.
Date of first participant enrolment
Anticipated
21/03/2022
Actual
Date of last participant enrolment
Anticipated
18/04/2022
Actual
Date of last data collection
Anticipated
17/10/2022
Actual
Sample size
Target
63
Accrual to date
Final
Recruitment outside Australia
Country [1] 24542 0
Viet Nam
State/province [1] 24542 0
Hanoi, Viet Nam

Funding & Sponsors
Funding source category [1] 310711 0
Government body
Name [1] 310711 0
Australian Defence Force Malaria and Infectious Disease Institute
Country [1] 310711 0
Australia
Primary sponsor type
Government body
Name
Australian Defence Force Malaria and Infectious Disease Institute
Address
Weary Dunlop Drive
Gallipoli Barracks
Enoggera, Brisbane QLD 4051
Country
Australia
Secondary sponsor category [1] 311928 0
University
Name [1] 311928 0
Vietnam Military Medical University
Address [1] 311928 0
160 Phung Hung, Ha Dong, Hanoi, Vietnam
Country [1] 311928 0
Viet Nam

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 310291 0
Vietnam Ministry of Health Institutional Review Boards in National Biomedical Research (MoH-IRBNBR)
Ethics committee address [1] 310291 0
Ethics committee country [1] 310291 0
Viet Nam
Date submitted for ethics approval [1] 310291 0
28/01/2022
Approval date [1] 310291 0
Ethics approval number [1] 310291 0
Ethics committee name [2] 310293 0
Australian Government Departments of Defence and Veterans’ Affairs Human Research Ethics Committee (DDVA HREC)
Ethics committee address [2] 310293 0
Ethics committee country [2] 310293 0
Australia
Date submitted for ethics approval [2] 310293 0
20/01/2022
Approval date [2] 310293 0
Ethics approval number [2] 310293 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117146 0
Prof Do Quyet
Address 117146 0
Vietnam Military Medical University (VMMU)
160 Phung Hung, Phuc La, Ha Dong, Hanoi, Vietnam
Country 117146 0
Viet Nam
Phone 117146 0
+84983301839
Fax 117146 0
Email 117146 0
dobaquyet@yahoo.com
Contact person for public queries
Name 117147 0
Do Quyet
Address 117147 0
Vietnam Military Medical University (VMMU)
160 Phung Hung, Phuc La, Ha Dong, Hanoi, Vietnam
Country 117147 0
Viet Nam
Phone 117147 0
+84983301839
Fax 117147 0
Email 117147 0
dobaquyet@yahoo.com
Contact person for scientific queries
Name 117148 0
Michael Edstein
Address 117148 0
Australian Defence Force Malaria Infectious Disease Institute (ADFMIDI)
Weary Dunlop Drive, Gallipoli Barracks, Enoggera, Brisbane, QLD 4051, Australia
Country 117148 0
Australia
Phone 117148 0
+61 403321689
Fax 117148 0
Email 117148 0
mike.edstein@defence.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
From 17 October 2023 to 17 October 2025
Available to whom?
Only to researchers who provide a methodologically sound proposal as well as a case-by-case basis at the discretion of the Sponsor
Available for what types of analyses?
Clinical and laboratory data for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (Prof. Dr. Do Quyet; dobaquyet@yahoo.com) and the Sponsor representative (Dr Michael Edstein: mike.edstein@defence.gov.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14958Study protocol  mike.edstein@defence.gov.au Study protocol submitted for ethical approval 383522-(Uploaded-06-02-2022-13-26-06)-Study-related document.docx
14959Informed consent form  mike.edstein@defence.gov.au Appendix A_Participant Information Sheet and Conse... [More Details] 383522-(Uploaded-09-02-2022-12-34-59)-Study-related document.docx
14960Clinical study report  mike.edstein@defence.gov.au To be submitted on completion of the study
14962Ethical approval  mike.edstein@defence.gov.au Ethics approval letters from the Vietnam Ministry ... [More Details]
15001Other  mike.edstein@defence.gov.au Appendix B_Drug regimen preference survey 383522-(Uploaded-09-02-2022-11-47-35)-Study-related document.docx
15002Other  mike.edstein@defence.gov.au Appendix C_Participant diary of tafenoquine admini... [More Details] 383522-(Uploaded-09-02-2022-12-38-30)-Study-related document.docx
15003Other    Appendix D_Sixty Degrees Pharmaceuticals-Prescribi... [More Details] 383522-(Uploaded-09-02-2022-12-38-06)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.