An Ultra-short Course of Primaquine for the Radical Cure of Vivax Malaria

NCT07468526 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: PRIMUSGTN2042278
• Study Type: interventional
• Target: 1,019
• Locations: 3 countries
• Sites: 4

Brief Summary

Current treatment regimens to prevent relapsing malaria are too long. A shorter higher dose treatment could improve treatment outcomes, but this needs to be balanced against increased risk of side effects. Recent data from a trial in children in Papua New Guinea (PNG) suggests a shortened treatment of 3 days is safe and effective. Our multicentre trial will assess the safety and efficacy of an ultra-short primaquine course. This trial is expected to directly influence global treatment policies.

Conditions

Malaria

Keywords

An ultra-short course of primaquine for the radical cure of vivax malaria; PRIMUS

Outcome Measures

Primary Outcomes (1)

• Incidence risk of any recurrent vivax parasitaemia within 4 months.

  The incidence risk (time to first event) of any recurrent P. vivax parasitaemia within 4 months as determined by microscopy

  4 Months

Secondary Outcomes (8)

• The incidence risk of any P. vivax parasitaemia within 6 months.

  6 months

• Incidence of haemoglobin drop >25% to <7g/dl within 14 days of treatment.

  0-14 days

• Incidence of moderate anaemia within 14 days after starting primaquine

  0-14 days

• Incidence of severe anaemia within 14 days after starting Primaquine

  0-14 days

• • The proportion of patients requiring blood transfusion within the 6 months follow up period.

  6 months

Study Arms (2)

High-dose Short-course Primaquine (PQ7)

ACTIVE COMPARATOR

Participants in this arm will receive a high-dose, short-course primaquine regimen (PQ7), consisting of a total dose of 7 mg/kg administered as 1 mg/kg once daily in the morning for 7 days (Day 0-6). A matching placebo will be given in the evening on the first three days (Day 0-2).

Drug: High dose ultra short Primaquine; Other: Placebo

High dose ultra- short course Primaquine (PQ 3.5)

EXPERIMENTAL

Participants in this arm will receive a high-dose, ultra-short primaquine regimen (PQ3.5), consisting of a total dose of 7 mg/kg administered as 1 mg/kg twice daily for 3.5 days (Day 0-2 morning and evening doses, and Day 3 morning dose). A matching placebo will be given as the morning dose on Days 4-6.

Drug: High dose ultra short Primaquine; Other: Placebo

Interventions

High dose ultra short Primaquine DRUG

High-dose, ultra-short primaquine (PQ3.5): 7mg/kg total dose given as 1mg/kg twice daily over 3.5 days (day 0, 1 and 2 morning and evening doses, and day 3 morning dose) followed by placebo as morning doses on day 4, 5 and 6.

High dose ultra- short course Primaquine (PQ 3.5); High-dose Short-course Primaquine (PQ7)

Placebo OTHER

Matching placebo administered according to the arm schedule. Morning dose on Days 4-6 for PQ3.5 arm and Evening dose on the first 3 days for PQ 7 arm).

High dose ultra- short course Primaquine (PQ 3.5); High-dose Short-course Primaquine (PQ7)

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• P. vivax peripheral parasitaemia as determined by microscopy
• G6PD normal status (G6PD activity ≥70% of the site specific adjusted male median as determined by the Standard G6PD (SD Bioline, ROK))
• Fever (temperature ≥37.5°C) or history of fever in the preceding 48 hours,
• Age ≥5 years
• Bodyweight ≥14kg
• Living in the study area and willing to be followed-up for six months

You may not qualify if:

• Signs or symptoms of severe malaria,
• Anaemia (defined as Hb \<8g/dl) and measured by the Standard G6PD
• Pregnant or lactating
• Blood transfusion within the preceding four months
• Regular or recent use (last month) of tafenoquine, primaquine or dapsone
• Known hypersensitivity to any of the study drugs

Sponsors & Collaborators

• Menzies School of Health Research: lead
• Curtin University: collaborator
• University of Melbourne: collaborator
• Papua New Guinea Institute of Medical Research: collaborator
• Arba Minch University: collaborator
• Jimma University: collaborator
• Universitas Sumatera Utara: collaborator
• Aga Khan University: collaborator
• PathWest Laboratory Medicine WA: collaborator

Study Sites (5)

Arba Minch University

Arba Minch, Arba Minch, Ethiopia

Location

Jimma University

Jimma, Jimma, Ethiopia

Location

Universitas Sumatera

Bandar Lampung, Lampung, Indonesia

Location

Aga Khan University, Karachi

Karachi, Thatta, Pakistan

Location

Papua New Guinea Institute of Medical Research

Port Moresby, Magang, Papua New Guinea

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Kamala Thriemer, Professor

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamala Thriemer, Professor

CONTACT

+61889468644; Kamala.Ley-Thriemer@menzies.edu.au

Hellen Mnjala, MSc

CONTACT

+61889468675; hellen.mnjala@menzies.edu.au

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Health care facility based, randomised, controlled, double blinded, trial with 2 arms

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: All the investigators involved in the study.

Locations

ID (1); PA (1); ET (2)