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Efficacy of Chloroquine (CQ) Alone Compared to Concomitant CQ and Primaquine for Plasmodium Vivax Infection

NCT02691910 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-02-25

No results posted yet for this study

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.

Conditions

  • Malaria, Vivax

Interventions

DRUG

Chloroquine

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.

DRUG

Primaquine

0.5 mg/kg once a day, for seven days. Total dose, 3.5mg/kg.

Sponsors & Collaborators

  • University of Sao Paulo

    collaborator OTHER

  • Oswaldo Cruz Foundation

    lead OTHER

Principal Investigators

  • MARCELO U FERREIRA, MD-PHD · Biomedical Sciences Institute of São Paulo University

  • SIMONE L ANDRADE, MD-PHD · Oswaldo Cruz Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-08-31
Completion
2015-09-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02691910 on ClinicalTrials.gov