EFFectiveness Of novel approaches to Radical cure with Tafenoquine and primaquine (EFFORT)- A randomized controlled trial in P. vivax patients

Tahapan Penelitian : Complete
Sponsor:
Mitra Pelaksana:
PT. Equilab International
No Registry
INA-9HZKZ0TP
Tanggal Input Registry : 25-03-2025

24-08-2022
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)
 
EFFectiveness Of novel approaches to Radical cure with Tafenoquine and primaquine (EFFORT)- A randomized controlled trial in P. vivax patients
EFFectiveness Of novel approaches to Radical cure with Tafenoquine and primaquine (EFFORT)- A randomized controlled trial in P. vivax patients
Interventional
Patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7), Patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ)
150
 

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 Bioline, ROK)), Fever (temperature ≥37.5°C) 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
 
532/KEPK/USU/2022
Waiting for approval
PPUK/PPUB number
Vicky Achmad Ginanjar