Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Study Overview
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Brief Summary
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Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

Detailed Description
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To assess the effectiveness of a short-course of high dose primaquine (total dose 7mg/kg given unsupervised over 7 days) compared to the current standard low dose primaquine regimen (total dose 3.5mg/kg given unsupervised over 14 days). To assess the effectiveness of tafenoquine (single dose of 300mg) compared to the short-course high dose primaquine regimen. To assess the safety of tafenoquine compared to the high and low dose primaquine regimens. To assess the cost-effectiveness and feasibility of high dose primaquine and tafenoquine compared to the current low dose primaquine regimen

Official Title
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Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients

Conditions
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Vivax Malaria, Plasmodium Vivax, Malaria, Vivax, Malaria Relapse

Intervention / Treatment
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* Drug: Tafenoquine
* Drug: Primaquine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria P. vivax peripheral parasitaemia (mono-infection) as determined by microscopy G6PD normal status (G6PD activity ≥ 70% of the adjusted male median as determined by the Biosensor™ (SD Biosensor, ROK)) Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours Age ≥18 years 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 Known hypersensitivity to any of the study drugs Regular use of drugs with haemolytic potential

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients are treated with schizontocidal treatment plus low dose PQ (total dose 3.5mg/kg) unsupervised over 14 days (PQ14) | |
| Experimental: PQ Intervention<br>Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7) | Drug: Primaquine<br>* patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)<br>* Other names: Primaquine 7 days;|
| Experimental: TQ Intervention<br>Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ) | Drug: Tafenoquine<br>* patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence risk any P vivax PQ7 / PQ14 | The incidence risk (time to first event) of any P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence risk any P vivax PQ7 / TQ | The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms | 6 months | 
| Incidence risk symptomatic P vivax TQ / PQ14 | The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between TQ and the control arm (PQ14). | 6 months | 
| Incidence risk any P vivax PQ7 / PQ14 | The incidence risk (time to first event) of symptomatic P. vivax parasitaemia during the 6-month follow up period as determined by microscopy compared between the PQ7 arm and the control arm (PQ14). | 6 months | 
| Incidence risk any P vivax PQ7 / TQ | • The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ7 and TQ arms | 6 months | 
| Incidence risk any P vivax PQ14 / TQ | The incidence risk (time to first event) of any P. vivax parasitaemia during the 6 months follow up period as determined by microscopy compared between PQ14 and TQ arms | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tafenoquine, primaquine