A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria (TADORE)

Menzies School of Health Research

Status and phase: Enrolling; Phase 3

Conditions: Vivax Malaria

Treatments: Drug: Tafenoquine; Drug: Primaquine

Study type: Interventional

Funder types: Other

Identifiers

NCT06148792

TADORE

Details and patient eligibility

About

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.

Enrollment: 1,090 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,090 participants in 3 patient groups

TQRevised

Experimental group

Description:

Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg)

Treatment:

Drug: Tafenoquine

TQStandard

Active Comparator group

Description:

Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard)

Treatment:

Drug: Tafenoquine

PQ7

Experimental group

Description:

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

Treatment:

Drug: Primaquine