A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
- Registration Number
- NCT06148792
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1090
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TQRevised Tafenoquine Patients are treated with schizontocidal treatment plus a single weight-based oral dose of TQ (target dose 7.5mg/kg) TQStandard Tafenoquine Patients are treated with schizontocidal treatment plus single fixed oral dose of 300mg TQ (TQStandard) PQ7 Primaquine Patients are treated with schizontocidal treatment plus oral high dose PQ (total dose 7 mg/kg) over 7 days (PQ7)
- Primary Outcome Measures
Name Time Method The incidence risk of vivax parasitaemia 4 months 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)
- Secondary Outcome Measures
Name Time Method The incidence risk of symptomatic vivax parasitaemia 6 months The incidence risk (time to first event) of symptomatic P. vivax parasitaemia at 6-month follow up as determined by microscopy
The incidence risk of vivax parasitaemia 6 months The incidence risk (time to first event) of any P. vivax parasitaemia at 6-month follow up as determined by microscopy
The incidence rate of vivax parasitaemia 6 months The incidence rate (events per person-time) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy
The incidence rate of symptomatic vivax parasitaemia 6 months The incidence rate (events per person-time) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy
The incidence risk of anaemia 7 and 14 days, 6 months 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
The incidence risk of an acute drop in Hb 7 and 14 days The incidence risk of an acute drop in Hb of \>25% to \<7g/dl within 7 and 14 days of starting treatment
Adverse events 42 days The number and proportion of adverse and serious adverse events in each arm within 42 days after start of treatment
Meth Hb concentration day 7 day 7 methaemoglobin concentration
Trial Locations
- Locations (4)
Dr Marcus Lacerda
🇧🇷Manaus, Brazil
Arba Minch General Hospital
🇪🇹Arba Minch, Ethiopia
Dr Rini Poespoprodjo
🇮🇩Timika, Indonesia
Dr Moses Laman and Dr Brioni Moore
🇵🇬Alexishafen, Papua New Guinea