Primaquine for Vivax Malaria in G6PD Intermediate and Deficient Cases.

A non randomized observation study that is aiming to assess the safety and efficacy of high dose primaquine (1mg/kg per day over 7 days) among patients with intermediate (30-70%) G6PD activity and the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (<30% activity)

Study Overview

• Status: Recruiting
• Conditions: Vivax Malaria; G6PD Deficiency
• Intervention / Treatment: Drug: Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days; Drug: Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • Manaus, Brazil
    • Recruiting
    • Dr Marcus Lacerda
    • Contact: Aretha Omena; Phone Number: +55984208810; Email: aretha.omena@gmail.com
• Ethiopia
  • Arba Minch, Ethiopia
    • Not yet recruiting
    • Arba Minch General Hospital
    • Contact: Tamiru Shibiru Degaga, MD; Phone Number: +251911704767; Email: tamiru.shibiru@menzies.edu.au
• Papua New Guinea
  • Madang Province
    • Alexishafen, Madang Province, Papua New Guinea
      • Recruiting
      • Dr Moses Laman and Dr Brioni Moore
      • Contact: Dr Paula Tesine Doctor, Medical Doctor; Phone Number: +67570755875; Email: paula.tesine@pngimr.org.pg
  • Magang
    • Port Moresby, Magang, Papua New Guinea
      • Recruiting
      • Papua New Guinea Institute of Medical Research
      • Contact: DR Moses Laman; Phone Number: +6754340208; Email: moses.laman@pngimr.org.pg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• • P. vivax peripheral parasitaemia (mono-infection)

  • G6PD intermediate or deficient status (G6PD activity 30-<70% or ≤30% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
  • Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
  • Age ≥18 years
  • Haemoglobin at presentation ≥8g/dl
  • Written informed consent
  • Living in the study area and willing to be followed for six months.

Exclusion Criteria:

• • Danger signs or symptoms of severe malaria

  • Pregnant or lactating females
  • Regular use of drugs with haemolytic potential
  • Known hypersensitivity to any of the study drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Participants with G6PD intermediate status receive another active regimen appropriate for intermedia; G6PD activity 30-<70%	Drug: Patients with G6PD enzyme activities between 30 and <70% of the AMM will be treated with schizontocidal treatment plus high dose primaquine 1mg/kg/day for 7 days; Primaquine 1mg/kg/day for 7 days
Active Comparator: Participants withG6PD deficient status receive a specific treatment regimen appropriate for deficie; G6PD activity ≤30%	Drug: Patients with G6PD enzyme activities <30% of the AMM will be treated with schizontocidal treatment plus 8 weekly primaquine (0.75mg/kg dose).; 8 weekly Primaquine (0.75mg/kg dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and efficacy of high dose primaquine	To assess the safety and efficacy of high dose primaquine (1mg/kg per day over 7 days) among patients with intermediate (30-70%) G6PD activity.; To assess the safety and efficacy of weekly primaquine among patients who are g6Pd deficient (<30% activity)	6 Months

Collaborators and Investigators

• Sponsor: Menzies School of Health Research
• Collaborators: Indonesia University; University of Melbourne; Curtin University; Oxford University Clinical Research Unit, Vietnam; Mahidol Oxford Tropical Medicine Research Unit; Papua New Guinea Institute of Medical Research; Arba Minch University

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Primaquine in G6PD deficiency; Vivax malaria in G6PD deficient patients
• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Infections; Hematologic Diseases; Protozoan Infections; Parasitic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Carbohydrate Metabolism, Inborn Errors; Malaria; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Malaria, Vivax; Glucosephosphate Dehydrogenase Deficiency; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinolines; Aminoquinolines; Primaquine
• Other Study ID Numbers: HREC 24-4988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No