Rigorous Assessment of P. Vivax Relapses and Primaquine Efficacy for Radical Cure
Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
Participant gender:
Summary
The study will be an open-labelled randomized clinical trial to determine therapeutic
efficacy. Note that this will not be an Investigational New Drug application, as only
WHO-approved drugs will be used at dosage and for conditions approved.
Eligible patients willing to participate will first be tested prior to enrolment for their
G6PD status by the gold standard spectrophotometric analysis. The investigators will exclude
from the study any G6PD deficient (or intermediate females) patient. Treatment allocation
will be randomized between i) 7 days of artesunate (2 mg/kg/day for 7 days) alone (Arm1), ii)
same artesunate regimen + 0.25 mg/kg/day 14 days of primaquine (Arm2) and iii) same
artesunate regimen + 0.5 mg/kg/day 14 days of primaquine (Arm3). All patients will be
relocated to a no-transmission city (Chbar Mon) to make sure they are not reinfected during
the follow-up. Follow-up will be performed every 24-48h for 90 days. At the end of the
follow-up period, all patients that did not receive primaquine (arm1) will be treated
according to national guidelines (14 days at 0.25mg/kg/day). Patients will additionally be
followed monthly for three months after the end of the relocation.
Phase:
N/A
Details
Lead Sponsor:
University of Maryland, Baltimore
Collaborators:
Cambodian National Centre for Parasitology Entomology and Malaria Control Institut Pasteur du Cambodge