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Recruiting NCT06148792

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Phase III Interventional Vivax Malaria

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tafenoquine, Primaquine.
Who it may be relevant to
Registry conditions: Vivax Malaria. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil, Ethiopia, Indonesia, Papua New Guinea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Tafenoquine
    oral treatment
  • Drug Primaquine
    oral treatment

Primary outcome measures

  • The incidence risk of vivax parasitaemia [Time frame: 4 months]
Secondary outcome measures (10)
  • The incidence risk of vivax parasitaemia [Time frame: 4 months]
  • The incidence risk of symptomatic vivax parasitaemia [Time frame: 4 months]
  • The incidence risk of vivax parasitaemia [Time frame: 6 months]
  • The incidence risk of symptomatic vivax parasitaemia [Time frame: 6 months]
  • The incidence rate of vivax parasitaemia [Time frame: 6 months]
  • The incidence rate of symptomatic vivax parasitaemia [Time frame: 6 months]
  • The incidence risk of anaemia [Time frame: 7 and 14 days, 6 months]
  • The incidence risk of an acute drop in Hb [Time frame: 7 and 14 days]
  • Adverse events [Time frame: 42 days]
  • Meth Hb concentration [Time frame: day 7]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Dr Marcus Lacerda — Manaus
Ethiopia · 1 center
  • Arba Minch General Hospital — Arba Minch
Indonesia · 1 center
  • Puskesmas Hanura — Hanura
Papua New Guinea · 1 center
  • Dr Moses Laman and Dr Brioni Moore — Alexishafen

Identifiers

NCT: NCT06148792 · TADORE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗