A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

NCT06148792 — Phase 3, Recruiting, 1090 participants, Menzies School of Health Research

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A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised

Registry	NCT06148792, acronym TADORE
Status	Recruiting
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	1090 (Estimated)
Sponsor	Menzies School of Health Research (Other); collaborators: University of Melbourne, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Arba Minch University, Addis Ababa University, Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia, Curtin University, Papua New Guinea Institute of Medical Research
Conditions	Vivax Malaria
Interventions	Tafenoquine, Primaquine (Drug)
Dates	start 2024-05-10, primary completion 2027-03-01 (estimated), completion 2027-03-01 (estimated), first posted 2023-11-28, last updated 2025-07-18
Locations	4 sites in Brazil, Ethiopia, Indonesia, Papua New Guinea

-Summary

The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\[s\] it aims to answer are:

* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days)
* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg)
* is the tolerability and safety of TQRevised acceptable
* is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.

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+Arms and interventions

Arm	Type	Interventions	Description
TQRevised	Experimental	Drug: Tafenoquine	Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)
TQStandard	Active comparator	Drug: Tafenoquine	Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)
PQ7	Experimental	Drug: Primaquine	Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)

Tafenoquine (Drug): oral treatment
Primaquine (Drug): oral treatment

+Outcome measures

Primary outcomes

The incidence risk of vivax parasitaemia [4 months]: The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy. * compared between TQRevised and the PQ7 (non-inferiority) * compared between TQRevised and TQStandard (superiority)

Secondary outcomes

The incidence risk of vivax parasitaemia [4 months]: The incidence risk (time to first event) of any P. vivax parasitaemia during the 4-month follow up period as determined by microscopy compared between TQStandard and PQ7
The incidence risk of symptomatic vivax parasitaemia [4 months]: The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy
The incidence risk of vivax parasitaemia [6 months]: The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy
The incidence risk of symptomatic vivax parasitaemia [6 months]: The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy
The incidence rate of vivax parasitaemia [6 months]: The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy
The incidence rate of symptomatic vivax parasitaemia [6 months]: The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy
The incidence risk of anaemia [7 and 14 days, 6 months]: The incidence risk of developing severe anaemia (Hb < 5g/dl) or moderate (5g/dl and <7g/dl) anaemia within 7 and 14 days of starting treatment and/or requiring blood transfusion within the 6 months follow up period
The incidence risk of an acute drop in Hb [7 and 14 days]: The incidence risk of an acute drop in Hb of >25% to <7g/dl within 7 and 14 days of starting treatment
Adverse events [42 days]: The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment
Meth Hb concentration [day 7]: day 7 methaemoglobin concentration

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* P. vivax peripheral parasitaemia (mono-infection)
* G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
* Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
* 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
* Regular use of drugs with haemolytic potential
* Known hypersensitivity to any of the study drugs.

+Locations (4)

Facility	City	Country	Status
Dr Marcus Lacerda	Manaus	Brazil	Recruiting
Arba Minch General Hospital	Arba Minch	Ethiopia	Recruiting
Puskesmas Hanura	Hanura	Indonesia	Not yet recruiting
Dr Moses Laman and Dr Brioni Moore	Alexishafen	Papua New Guinea	Recruiting

+Investigators

Kamala N Thriemer, PhD, Principal investigator, Menzies School of Health Research

My Notes

Public

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