TADORE: A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria
Study Details
Study Description
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)
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is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg)
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is the tolerability and safety of TQRevised acceptable
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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 | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TQRevised Patients are treated with schizontocidal treatment plus a single weight-based dose of TQ (target dose 7.5mg/kg) |
Drug: Tafenoquine
see arm/group description
|
| Active Comparator: TQStandard Patients are treated with schizontocidal treatment plus single fixed dose of 300mg TQ (TQStandard) |
Drug: Tafenoquine
see arm/group description
|
| Experimental: PQ7 Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) over 7 days (PQ7) |
Drug: Primaquin
see arm/group description
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 TQStandard and PQ7
- The incidence risk of symptomatic vivax parasitaemia [4 months]
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 4 months follow up period 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 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 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr Marcus Lacerda | Manaus | Brazil | ||
| 2 | Arba Minch General Hospital | Arba Minch | Ethiopia | ||
| 3 | Dr Rini Poespoprodjo | Timika | Indonesia | ||
| 4 | Dr Moses Laman and Dr Brioni Moore | Alexishafen | Papua New Guinea |
Sponsors and Collaborators
- Menzies School of Health Research
- University of Melbourne
- Fundação de Medicina Tropical Dr. Heitor Vieira Dourado
- Arba Minch University
- Addis Ababa University
- Papuan Community Health and Development Foundation, Indonesia
- Eijkman Research Center for Molecular Biology, National Research and Innovation Agency, Indonesia
- Curtin University
- Papua New Guinea Institute of Medical Research
Investigators
- Principal Investigator: Kamala N Thriemer, PhD, Menzies School of Health Research
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TADORE