A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

Vivax Malaria Clinical Trial

— TADORE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06148792
• Other study ID #: TADORE
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Est. completion date: March 1, 2027

Study information

• Verified date: February 2024
• Source: Menzies School of Health Research
• Contact: Hellen Mnjala
• Phone: +610889468675
• Email: hellen.mnjala[@]menzies.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1090
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 =37.5°C) 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.

Related Conditions & MeSH terms

• Malaria
• Malaria, Vivax
• Vivax Malaria

Intervention

Drug:
• Tafenoquine
oral treatment
• Primaquine
oral treatment

Locations

Country	Name	City	State
Brazil	Dr Marcus Lacerda	Manaus
Ethiopia	Arba Minch General Hospital	Arba Minch
Indonesia	Dr Rini Poespoprodjo	Timika
Papua New Guinea	Dr Moses Laman and Dr Brioni Moore	Alexishafen

Sponsors (9)

Lead Sponsor	Collaborator
Menzies School of Health Research	Addis Ababa University, Arba Minch University, Curtin University, Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia, Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Papua New Guinea Institute of Medical Research, Papuan Community Health and Development Foundation, Indonesia, University of Melbourne

Countries where clinical trial is conducted

Brazil,  Ethiopia,  Indonesia,  Papua New Guinea, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence risk of vivax parasitaemia	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)	4 months
Secondary	The incidence risk of vivax parasitaemia	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	4 months
Secondary	The incidence risk of symptomatic vivax parasitaemia	The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period as determined by microscopy	4 months
Secondary	The incidence risk of vivax parasitaemia	The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy	6 months
Secondary	The incidence risk of symptomatic vivax parasitaemia	The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy	6 months
Secondary	The incidence rate of vivax parasitaemia	The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy	6 months
Secondary	The incidence rate of symptomatic vivax parasitaemia	The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy	6 months
Secondary	The incidence risk of anaemia	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	7 and 14 days, 6 months
Secondary	The incidence risk of an acute drop in Hb	The incidence risk of an acute drop in Hb of >25% to <7g/dl within 7 and 14 days of starting treatment	7 and 14 days
Secondary	Adverse events	The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment	42 days
Secondary	Meth Hb concentration	day 7 methaemoglobin concentration	day 7