Clinical trial NCT04411836: Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine
Official title: Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine - a Randomized Controlled Trial in P. Vivax Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vivax Malaria
Plasmodium Vivax
Malaria, Vivax
Malaria Relapse
Keywords: tafenoquine
primaquine
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: University of Melbourne
name: National Centre for Parasitology, Entomology and Malaria Control, Cambodia
name: Mahidol Oxford Tropical Medicine Research Unit
name: Ethiopian Public Health Institute
name: Universitas Sumatera Utara
name: Arba Minch University
name: Aga Khan University
First posted: 2020-06-02
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: * 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

Eligibility criteria: 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

Primary outcomes:
measure: Incidence risk any P vivax PQ7 / PQ14
timeFrame: 6 months
Secondary outcomes:
measure: Incidence risk any P vivax PQ7 / TQ
timeFrame: 6 months
measure: Incidence risk symptomatic P vivax TQ / PQ14
timeFrame: 6 months
measure: Incidence risk any P vivax PQ7 / PQ14
timeFrame: 6 months
measure: Incidence risk any P vivax PQ7 / TQ
timeFrame: 6 months
measure: Incidence risk any P vivax PQ14 / TQ
timeFrame: 6 months
Other outcomes:
Locations:
city: Pursat
country: Cambodia
facility: Kravanh District Hospital
state: Pursat Province
city: Kampong Speu
country: Cambodia
facility: Chambak Health Center
city: Stung Treng
country: Cambodia
facility: Siem Pang Health Centre
city: Arba Minch
country: Ethiopia
facility: Arba Minch General Hospital
city: Labuhanbatu
country: Indonesia
facility: Tanjung Leidong Health Center
state: Sumatera
city: Karachi
country: Pakistan
facility: Aga Khan Hospital Karachi
Study officials:
affiliation: Menzies School of Health Research
name: Kamala Thriemer, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: