Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine

Menzies School of Health Research960 enrolled

Overview

Health care facility based, randomized, controlled, open label, superiority trial with 3 arms

* 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

960

Conditions

Vivax Malaria Plasmodium Vivax Malaria, Vivax Malaria Relapse

Interventions

TafenoquineDRUG

patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).

PrimaquineDRUG

patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (6)

Kravanh District Hospital

Pursat, Pursat, Cambodia

Chambak Health Center

Kampong Speu, Cambodia

Siem Pang Health Centre

Stung Treng, Cambodia

Arba Minch General Hospital

Arba Minch, Ethiopia

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

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

Time frame: 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).

Time frame: 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).

Time frame: 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

Time frame: 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

Time frame: 6 months

Data from ClinicalTrials.gov

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