Primaquine Double Dose for Radical Cure of Plasmodium Vivax in Colombia
Status:
Not yet recruiting
Trial end date:
2023-04-30
Target enrollment:
Participant gender:
Summary
Primaquine (PQ) is the only widely available treatment to prevent P. vivax relapses. World
Health Organization recommends increased PQ doses in East Asia and Oceania, frequently
relapsing strains. In 2005, the Centers for Diseases Control and Prevention began also
recommending higher dose PQ to treat infections from all parts of the world.
In Latin America, PQ for a radical cure has been largely implemented as 3.5 mg/kg over 14
days (standard dose, long-course, PQsd14) or 3.5 mg/kg over 7 days (short-course, or PQsd7)
in combination with chloroquine (CQ). A recent randomized controlled trial in Brazil showed
that a 7 mg/kg double dose regimen over 14 days (PQdd14) was superior in preventing relapses
compared to the standard of care regimen in Brazil of 3.5 mg/kg over 7 PQsd7 Direct Observed
Therapy (DOT) and PQsd7 without DOT and with or 14 days PQsd14 with DOT (92% versus 66% were
relapse-free in the 6-month follow-up in adjusted analyses). These data were presented at the
2019 PAHO Malaria Technical Advisory Group (TAG) meeting. To inform whether there should be a
policy change by Panamerican Health Organization, the Malaria TAG recommended more evidence
from the results of another trial to confirm the efficacy of high versus low-dose PQ. This
project aims to generate the necessary evidence to inform a policy decision regarding
high-dose PQ.
Impact Malaria (IM) proposes to conduct another trial, per the PAHO Malaria TAG's
recommendation, assessing the efficacy of high-dose PQ compared to low-dose PQ. The objective
is to compare a standard regimen, which in Colombia is PQsd14 (3,5mg/kg divided in 14 days),
to a double dose alternative PQ 7 mg/kg double dose regimen over 14 days (PQdd14).