Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine
EFFORT
1 other identifier
interventional
960
4 countries
6
Brief Summary
Health care facility based, randomized, controlled, open label, superiority trial with 3 arms
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2021
Typical duration for phase_3
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2020
CompletedFirst Posted
Study publicly available on registry
June 2, 2020
CompletedStudy Start
First participant enrolled
April 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedOctober 8, 2024
October 1, 2024
3.4 years
May 28, 2020
October 3, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence risk any P vivax PQ7 / PQ14
The incidence risk (time to first event) of any P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).
6 months
Secondary Outcomes (5)
Incidence risk any P vivax PQ7 / TQ
6 months
Incidence risk symptomatic P vivax TQ / PQ14
6 months
Incidence risk any P vivax PQ7 / PQ14
6 months
Incidence risk any P vivax PQ7 / TQ
6 months
Incidence risk any P vivax PQ14 / TQ
6 months
Study Arms (3)
Control
NO INTERVENTIONPatients are treated with schizontocidal treatment plus low dose PQ (total dose 3.5mg/kg) unsupervised over 14 days (PQ14)
PQ Intervention
EXPERIMENTALPatients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)
TQ Intervention
EXPERIMENTALPatients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ)
Interventions
patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).
patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)
Eligibility Criteria
You may qualify if:
- P. vivax peripheral parasitaemia (mono-infection) as determined by microscopy
- G6PD normal status (G6PD activity ≥ 70% of the adjusted male median as determined by the Biosensor™ (SD Biosensor, ROK))
- Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
- Age ≥18 years
- Written informed consent
- Living in the study area and willing to be followed for six months
You may not qualify if:
- Danger signs or symptoms of severe malaria
- Anaemia (defined as Hb \<8g/dl)
- Pregnant or lactating females
- Known hypersensitivity to any of the study drugs
- Regular use of drugs with haemolytic potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Menzies School of Health Researchlead
- University of Melbournecollaborator
- National Centre for Parasitology, Entomology and Malaria Control, Cambodiacollaborator
- Mahidol Oxford Tropical Medicine Research Unitcollaborator
- Ethiopian Public Health Institutecollaborator
- Universitas Sumatera Utaracollaborator
- Arba Minch Universitycollaborator
- Aga Khan Universitycollaborator
Study Sites (6)
Kravanh District Hospital
Pursat, Pursat, Cambodia
Chambak Health Center
Kampong Speu, Cambodia
Siem Pang Health Centre
Stung Treng, Cambodia
Arba Minch General Hospital
Arba Minch, Ethiopia
Tanjung Leidong Health Center
Labuhanbatu, Sumatera, Indonesia
Aga Khan Hospital Karachi
Karachi, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kamala Thriemer, MD, MPH, PhD
Menzies School of Health Research
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2020
First Posted
June 2, 2020
Study Start
April 25, 2021
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Access Criteria
- The data are available for access via the WorldWide Antimalarial Resistance Network (WWARN.org). Requests for access will be reviewed by a Data Access Committee to ensure that use of data protects the interests of the participants and researchers according to the terms of ethics approval and principles of equitable data sharing. Requests can be submitted by email to malariaDAC@iddo.org via the Data Access Form available at WWARN.org/accessing-data. The WWARN is registered with the Registry of Research Data Repositories (re3data.org).
Study Protocol and Statistical Analysis Plan will be made available to others. Data collected for the study, including individual patient data and the final trial dataset are reserved for the chief investigator and co-investigators of the trial. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. Trial results will be published in peer-reviewed open access journals and disseminated to trial stakeholders, including participants, as per ethical guidelines.