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Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine (EFFORT)

Primary Purpose

Vivax Malaria, Plasmodium Vivax, Malaria, Vivax

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tafenoquine
Primaquine
Sponsored by
Menzies School of Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vivax Malaria focused on measuring tafenoquine, primaquine

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Kravanh District HospitalRecruiting
  • Chambak Health Center
  • Siem Pang Health CentreRecruiting
  • Arba Minch General HospitalRecruiting
  • Tanjung Leidong Health CenterRecruiting
  • Aga Khan Hospital Karachi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

PQ Intervention

TQ Intervention

Arm Description

Patients are treated with schizontocidal treatment plus low dose PQ (total dose 3.5mg/kg) unsupervised over 14 days (PQ14)

Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Incidence risk any P vivax PQ7 / TQ
The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms
Incidence risk symptomatic P vivax TQ / PQ14
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between TQ and the control arm (PQ14).
Incidence risk any P vivax PQ7 / PQ14
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).
Incidence risk any P vivax PQ7 / TQ
• The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms
Incidence risk any P vivax PQ14 / TQ
The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ14 and TQ arms

Full Information

First Posted
May 28, 2020
Last Updated
June 19, 2023
Sponsor
Menzies School of Health Research
Collaborators
University of Melbourne, National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Mahidol Oxford Tropical Medicine Research Unit, Ethiopian Public Health Institute, Universitas Sumatera Utara, Arba Minch University, Aga Khan University
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1. Study Identification

Unique Protocol Identification Number
NCT04411836
Brief Title
Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine
Acronym
EFFORT
Official Title
Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menzies School of Health Research
Collaborators
University of Melbourne, National Centre for Parasitology, Entomology and Malaria Control, Cambodia, Mahidol Oxford Tropical Medicine Research Unit, Ethiopian Public Health Institute, Universitas Sumatera Utara, Arba Minch University, Aga Khan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Health care facility based, randomized, controlled, open label, superiority trial with 3 arms
Detailed Description
To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days). To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen. To assess the safety of tafenoquine compared to the high and low dose primaquine regimens. To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vivax Malaria, Plasmodium Vivax, Malaria, Vivax, Malaria Relapse
Keywords
tafenoquine, primaquine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
960 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients are treated with schizontocidal treatment plus low dose PQ (total dose 3.5mg/kg) unsupervised over 14 days (PQ14)
Arm Title
PQ Intervention
Arm Type
Experimental
Arm Description
Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)
Arm Title
TQ Intervention
Arm Type
Experimental
Arm Description
Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ)
Intervention Type
Drug
Intervention Name(s)
Tafenoquine
Intervention Description
patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).
Intervention Type
Drug
Intervention Name(s)
Primaquine
Other Intervention Name(s)
Primaquine 7 days
Intervention Description
patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)
Primary Outcome Measure Information:
Title
Incidence risk any P vivax PQ7 / PQ14
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Incidence risk any P vivax PQ7 / TQ
Description
The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms
Time Frame
6 months
Title
Incidence risk symptomatic P vivax TQ / PQ14
Description
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between TQ and the control arm (PQ14).
Time Frame
6 months
Title
Incidence risk any P vivax PQ7 / PQ14
Description
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14).
Time Frame
6 months
Title
Incidence risk any P vivax PQ7 / TQ
Description
• The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms
Time Frame
6 months
Title
Incidence risk any P vivax PQ14 / TQ
Description
The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ14 and TQ arms
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kamala Thriemer, MD, MPH, PhD
Phone
0889468644
Email
kamala.ley-thriemer@menzies.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamala Thriemer, MD, MPH, PhD
Organizational Affiliation
Menzies School of Health Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kravanh District Hospital
City
Pursat
State/Province
Pursat Province
Country
Cambodia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupam Tripura, MD
First Name & Middle Initial & Last Name & Degree
Lorenz von Seidlein, MD
First Name & Middle Initial & Last Name & Degree
Lek Dysoley, MD
First Name & Middle Initial & Last Name & Degree
Rupam Tripura, MD
First Name & Middle Initial & Last Name & Degree
Tom Peto, PhD
First Name & Middle Initial & Last Name & Degree
James Callery, MD
Facility Name
Chambak Health Center
City
Kampong Speu
Country
Cambodia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupam Tripura, MD
First Name & Middle Initial & Last Name & Degree
Lorenz Seidlein, MD
First Name & Middle Initial & Last Name & Degree
Lek Dysoley, MD
First Name & Middle Initial & Last Name & Degree
James Callery, MD
First Name & Middle Initial & Last Name & Degree
Thomas Peto, MD
First Name & Middle Initial & Last Name & Degree
Rupam Tripura, MD
Facility Name
Siem Pang Health Centre
City
Stung Treng
Country
Cambodia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rupam Tripura, MD
First Name & Middle Initial & Last Name & Degree
Lorenz von Seidlein, MD
First Name & Middle Initial & Last Name & Degree
Lek Dysoley, MD
First Name & Middle Initial & Last Name & Degree
Rupam Tripura, MD
First Name & Middle Initial & Last Name & Degree
Tom Peto, PhD
First Name & Middle Initial & Last Name & Degree
James Callery, MD
Facility Name
Arba Minch General Hospital
City
Arba Minch
Country
Ethiopia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamiru Shibiru Degaga, MD
Facility Name
Tanjung Leidong Health Center
City
Labuhanbatu
State/Province
Sumatera
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayodhia Pasaribu Pitaloka, MD
Facility Name
Aga Khan Hospital Karachi
City
Karachi
Country
Pakistan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asim Beg, MD
First Name & Middle Initial & Last Name & Degree
Asim Beg, MD
First Name & Middle Initial & Last Name & Degree
Najia Ghanchi, MD
First Name & Middle Initial & Last Name & Degree
Momin Kazi, MD
First Name & Middle Initial & Last Name & Degree
Farah Qamar, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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).
IPD Sharing URL
http://WWARN.org/accessing-data

Learn more about this trial

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

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