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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,090
oral treatment
oral treatment
Dr Marcus Lacerda
Manaus, Brazil
RECRUITINGArba Minch General Hospital
Arba Minch, Ethiopia
RECRUITINGPuskesmas Hanura
Hanura, Indonesia
NOT_YET_RECRUITINGDr Moses Laman and Dr Brioni Moore
Alexishafen, Papua New Guinea
RECRUITINGThe 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)
Time frame: 4 months
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
Time frame: 4 months
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
Time frame: 4 months
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 6 months
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
Time frame: 7 and 14 days, 6 months
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
Time frame: 7 and 14 days
Adverse events
The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment
Time frame: 42 days
Meth Hb concentration
day 7 methaemoglobin concentration
Time frame: day 7
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