Efficacy of Chloroquine-Primaquine Treatment for Uncomplicated Plasmodium Vivax Malaria

NCT07753967 | Completed DMC

• 2 other identifiers: Institutional Review BoardJU_IRB
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CQ- PQ,; Efficacy; Adequate clinical and parasitological response; Southwest ethiopia

Outcome Measures

Primary Outcomes (2)

• To assess the efficacy of Chloroquine (CQ) and Primaquine (PQ) against P.vivax infections in Ethiopia by recording recrudescent rates .

  This study assesses the efficacy of Chloroquine (CQ) and Primaquine (PQ) by recording recrudescent rates with supervised and without supervision groups

  42 days

• To assess the efficacy of Chloroquine (CQ) and Primaquine (PQ) against P.vivax infections in Ethiopia by recording parasitic clearance (adequate clinical and parasitological responses)

  This study assesses the efficacy of Chloroquine (CQ) and Primaquine (PQ) by recording parasitic clearance (adequate clinical and parasitological responses) in uncomplicated P.vivax patients who are given a standard dose of Chloroquine and primaquine treatment in supervised and without supervision groups

  42 days

Secondary Outcomes (1)

• the adherence rate of vivax malaria patients treated with CQ and PQ.

  14 days

Other Outcomes (1)

• Number of participants with direct face-to-face interviews to assess the safety and tolerability of the CQ and PQ drugs

  14 days

Study Arms (1)

Spervised vs unsupervised

OTHER

The symptomatic vivax malaria patients were enrolled and randomly assigned to one of two treatment groups; Supervised (treatment closely monitored) and unsupervised (treatment without monitoring and supervision).

Drug: CQ-PQ

Interventions

CQ-PQ DRUG

Supervised Vs unsupervised CQ-PQ efficacy testing

Spervised vs unsupervised

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Jimma University: lead

Study Sites (1)

Jimma Health Center

Jimma, Oromiya, 1000, Ethiopia

Location

MeSH Terms

Conditions

Malaria, Vivax

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Ketema Bedanie Bacha, PhD

  Jimma University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: An open-label, two-arm clinical trial

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 10, 2026
• Study Start: December 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: November 30, 2025
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)