Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04411836

Acronym

EFFORT

Enrollment

960

Registered

2020-06-02

Start date

2021-04-25

Completion date

2024-09-30

Last updated

2024-10-08

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

Conditions

Vivax Malaria, Plasmodium Vivax, Malaria, Vivax, Malaria Relapse

Keywords

tafenoquine, primaquine

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

Interventions

DRUGTafenoquine

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

DRUGPrimaquine

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Incidence risk any P vivax PQ7 / PQ14	6 months	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

Measure	Time frame	Description
Incidence risk any P vivax PQ7 / TQ	6 months	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	6 months	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	6 months	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 PQ14 / TQ	6 months	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

Countries

Cambodia, Ethiopia, Indonesia, Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026