CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 257 enrolled
Drug / intervention
Primaquinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03610399
NCT03610399N/ACompleted

Efficacy of Three Regimens of Chloroquine and Primaquine for the Treatment of Plasmodium Vivax Malaria in Cruzeiro do Sul, Acre, Brazil

Centers for Disease Control and Prevention·interventional·Posted Aug 1, 2018·Updated Aug 9, 2021

In Brief

A clinical study evaluating Primaquine for P Vivax and Malaria, Vivax. Completed, enrolled 257 participants across 1 site.

Detailed Summary

We plan to assess the efficacy of 3 different regimens of chloroquine and primaquine for the treatment of P. vivax infections in Cruzeiro do Sul, Acre, Brazil. Patients will be divided in 3 different groups: treatment with regular dose of primaquine (0.5 mg/kg per day for 7 days) with directly observed therapy; regular dose of primaquine without directly observed therapy; and increased total dose of primaquine (0.5 mg/kg per day for14 days) with directly observed therapy. All patients will receive chloroquine (CQ) for three days at a daily dose of approximately 25 mg/Kg in accordance with the Brazilian National Malaria Control guidelines. Clinical and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and for a total period of 168 days (24 weeks) to evaluate chances of recrudescence, relapse, or reinfection. Results from this drug efficacy study will be used to assist the Brazilian Ministry of Health in assessing their national malaria treatment policy for P. vivax malaria.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 1, 2018
Enrollment StartApr 9, 2018
Primary CompletionMar 12, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.9 years ago

Interventions

Primaquinedrug

Different total dose and supervision.