Status:
COMPLETED
Effectiveness of Novel Approaches to Radical Cure With Tafenoquine and Primaquine
Lead Sponsor:
Menzies School of Health Research
Collaborating Sponsors:
University of Melbourne
National Centre for Parasitology, Entomology and Malaria Control, Cambodia
Conditions:
Vivax Malaria
Plasmodium Vivax
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 3.5m...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
April 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
960 Patients enrolled
Trial Details
Trial ID
NCT04411836
Start Date
April 25 2021
End Date
September 30 2024
Last Update
October 8 2024
Active Locations (6)
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1
Kravanh District Hospital
Pursat, Pursat, Cambodia
2
Chambak Health Center
Kampong Speu, Cambodia
3
Siem Pang Health Centre
Stung Treng, Cambodia
4
Arba Minch General Hospital
Arba Minch, Ethiopia