DHA-PQP vs Chloroquine and Primaquine for Radical Cure of Vivax Malaria in Brazil

Summary

Plasmodium vivax can be cause of severe malaria and mortality. There are serious public health implications associated with cases of P. vivax resistant to Chloroquine in the Americas as well there are efforts of many countries to eliminate this disease. In this way, it is critically important to evaluate an alternative radical cure treatment efficient to amazon scenario. The objectives of this trial are to demonstrate the superiority of adequate parasitological response at D42 of Dihydroartemisinin plus Piperaquine (DHA-PQP or Eurartesim®) versus Chloroquine and to evaluate the proportion of failure until D180 considering different starting days of Primaquine (0.50 mg/kg/day) for 14 days. It is an open, 4 arms, randomised, comparative trial. Total of 460 patients are initially planned to be included. To demonstrate the superiority of DHA-PQP compared to Chloroquine, the 95% confidence interval of the difference observed between both treatment success rates will be determined. Each recurrence will be passively and actively detected for 180 days.

Conditions

• Malaria, Vivax
• Therapeutics

Interventions

DRUG

CQ coadministered with PQ

113 subjects in a 3-day regimen treatment with the schizonticidal drug Chloroquine concomitantly to 14-day regimen treatment with Primaquine in a dose of 0.50 mg/kg/day.

DRUG

DHA-PQP coadministered with PQ

In this treatment group, 112 subjects took DHA-PQP for three days and Primaquine for 14 days in the following dose: 0.50 mg/kg/day.

DRUG

CQ and PQ starting on Day 42

98 subjects in a 3-day regimen treatment with Chloroquine with a 14-day regimen treatment with Primaquine in a dose of 0.50 mg/kg/day starting on Day 42 after first dose of the schizonticidal drug.

DRUG

DHA-PQP and PQ starting on Day 42

95 subjects in a 3-day regimen treatment with DHA-PQP with a 14-day regimen treatment with Primaquine in a dose of 0.50 mg/kg/day starting on Day 42 after first dose of the schizonticidal drug.

Sponsors & Collaborators

• Ministry of Health, Brazil

  collaborator OTHER_GOV

• Oswaldo Cruz Foundation

  collaborator OTHER

• Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

  lead OTHER

Principal Investigators

• Marcus VG de Lacerda, MD, PhD · Fundação de Medicina Tropical Dr. Heitor Vieira Dourado

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

6 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-05

Primary Completion

2021-07-02

Completion

2021-07-02

Countries

• Brazil

Study Locations