Clinical trial NCT06148792: A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Official title: A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria - TAfenoquine DOsing REvised
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Vivax Malaria
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
name: Arba Minch University
name: Addis Ababa University
name: Papuan Community Health and Development Foundation, Indonesia
name: Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia
name: Curtin University
name: Papua New Guinea Institute of Medical Research
First posted: 2023-11-28
Enrollment: 1090
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The incidence risk of vivax parasitaemia
timeFrame: 4 months
Secondary outcomes:
measure: The incidence risk of vivax parasitaemia
timeFrame: 4 months
measure: The incidence risk of symptomatic vivax parasitaemia
timeFrame: 4 months
measure: The incidence risk of vivax parasitaemia
timeFrame: 6 months
measure: The incidence risk of symptomatic vivax parasitaemia
timeFrame: 6 months
measure: The incidence rate of vivax parasitaemia
timeFrame: 6 months
measure: The incidence rate of symptomatic vivax parasitaemia
timeFrame: 6 months
measure: The incidence risk of anaemia
timeFrame: 7 and 14 days, 6 months
measure: The incidence risk of an acute drop in Hb
timeFrame: 7 and 14 days
measure: Adverse events
timeFrame: 42 days
measure: Meth Hb concentration
timeFrame: day 7
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Dr Marcus Lacerda
city: Arba Minch
country: Ethiopia
facility: Arba Minch General Hospital
city: Timika
country: Indonesia
facility: Dr Rini Poespoprodjo
city: Alexishafen
country: Papua New Guinea
facility: Dr Moses Laman and Dr Brioni Moore
Study officials:
affiliation: Menzies School of Health Research
name: Kamala N Thriemer, PhD
role: PRINCIPAL_INVESTIGATOR
References: