MedTrace Logo

Efficacy of Chloroquine-Primaquine Treatment for Uncomplicated Plasmodium Vivax Malaria

NCT07753967 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2026-08-10

No results posted yet for this study

Summary

The study was designed to evaluate the current efficacy of this combination therapy against P. vivax, given the possibility of misuse or inadequate adherence to the regimen due to its lengthy treatment duration, in one of a vivax-endemic area in southwest Ethiopia. A 42-day in vivo drug efficacy study was carried out as an open, two arm clinical trial involving 192 patients with uncomplicated P. vivax mono infection. Participants were allocated into two groups: supervised (n = 96) and unsupervised (n = 96). Both groups received CQ, 25 mg/kg over 3 days) and PQ, 0.25 mg/kg/day for 14 days). In the supervised group, treatment was administered under direct monitoring by healthcare providers and follow up was scheduled according to the World Health Organization (WHO) recommended drug efficacy testing protocol. Whereas patients in the unsupervised group were instructed to take their medication at home without direct monitoring and were advised to adhere to the treatment regimen. Their medication adherence and malaria episodes were monitored through scheduled phone follow ups.

Conditions

  • Malaria Vivax

Interventions

DRUG

CQ-PQ

Supervised Vs unsupervised CQ-PQ efficacy testing

Sponsors & Collaborators

  • Jimma University

    lead OTHER

Principal Investigators

  • Ketema Bedanie Bacha, PhD · Jimma University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2024-12-01
Completion
2025-11-30

Countries

  • Ethiopia

Study Locations

More Related Trials

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 NCT07753967 on ClinicalTrials.gov