At a glance
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Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine (PQ) for the Treatment of Uncomplicated Plasmodium Vivax Infection
In Brief
A Phase 3 clinical trial evaluating Chloroquine and Primaquine for Malaria, Vivax. Completed, enrolled 204 participants across 2 sites.
Detailed Summary
This is a randomized open-label trial to evaluate the efficacy of chloroquine (CQ) alone compared to chloroquine+primaquine (CQ+PQ) in the treatment of uncomplicated malaria caused by Plasmodium vivax infection in a endemic area in the westernmost part of the Amazon Basin of Brazil. The duration of follow up for evaluating CQ efficacy as a schizonticidal drug was 28 days. The duration of complete follow up to detect recurrent P. vivax infections by passive surveillance was six months. All patients in the CQ alone arm received 7 days of PQ treatment (3.5mg/kg total dose) starting on day 28 of the study follow-up.
Study Details
Timeline
Interventions
10mg/kg on day 0 and 7.5mg/kg on days 1 and 2. Total dose, 25 mg base/kg. Tablet containing 150mg of base.
0.5 mg/kg once a day, for seven days. Total dose, 3.5mg/kg.