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NCT06148792 | RECRUITING | Vivax Malaria

A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Sponsor:

Menzies School of Health Research

Brief 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.

Condition or disease

Vivax Malaria

Intervention/treatment

Tafenoquine

Primaquine

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1090 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised
Actual Study Start Date : 2024-05-10
Estimated Primary Completion Date : 2027-03-01
Estimated Study Completion Date : 2027-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Location Details

NCT06148792

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Brazil,

Dr Marcus Lacerda

Manaus, Brazil,

RECRUITING

Ethiopia,

Arba Minch General Hospital

Arba Minch, Ethiopia,

NOT YET RECRUITING

Indonesia,

Dr. Rini Poespoprodjo

Timika, Indonesia,

NOT YET RECRUITING

Papua new guinea,

Dr. Moses page and Dr. Brioni Moore

Alexishafen, Papua new guinea,