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

March 9, 2026 updated by: Menzies School of Health Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1019

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Ethiopia
    • Arba Minch
      • Arba Minch, Arba Minch, Ethiopia
        • Arba Minch University
        • Contact:
        • Principal Investigator:
          • Dr Tamiru Degaga
    • Jimma
      • Jimma, Jimma, Ethiopia
        • Jimma University
        • Contact:
        • Principal Investigator:
          • Dr Daniel Yilma
  • Indonesia
    • Lampung
      • Bandar Lampung, Lampung, Indonesia
        • Universitas Sumatera
        • Contact:
          • Dr Ayodhia Pitaloka Pasaribu, Professor
          • Phone Number: +628126024392
          • Email: ayodhia@usu.ac.id
        • Principal Investigator:
          • Dr Ayodhia Pitaloka Pasaribu
  • Pakistan
    • Thatta
      • Karachi, Thatta, Pakistan
        • Aga Khan University, Karachi
        • Contact:
        • Principal Investigator:
          • Dr Asim Beg
  • Papua New Guinea
    • Magang
      • Port Moresby, Magang, Papua New Guinea
        • Papua New Guinea Institute of Medical Research
        • Contact:
        • Principal Investigator:
          • Dr Moses Laman

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High-dose Short-course Primaquine (PQ7)
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
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.
Other: Placebo
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).
Experimental: High dose ultra- short course Primaquine (PQ 3.5)
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
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.
Other: Placebo
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence risk of any recurrent vivax parasitaemia within 4 months.
Time Frame: 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence risk of any P. vivax parasitaemia within 6 months.
Time Frame: 6 months
The incidence risk (time to first event) of any P. vivax parasitaemia within 6 months as determined by microscopy
6 months
Incidence of haemoglobin drop >25% to <7g/dl within 14 days of treatment.
Time Frame: 0-14 days
Number of participants experiencing a haemoglobin decrease of >25% from baseline resulting in Hb<7g/dl
0-14 days
Incidence of moderate anaemia within 14 days after starting primaquine
Time Frame: 0-14 days
Number of participants developing haemoglobin >=5g/dl and <7g/dl within 14 days after treatment initiation
0-14 days
Incidence of severe anaemia within 14 days after starting Primaquine
Time Frame: 0-14 days
Number of participants developing haemoglobin <5g/dl within 14 days of treatment initiation.
0-14 days
• The proportion of patients requiring blood transfusion within the 6 months follow up period.
Time Frame: 6 months
Participants requiring transfusion due to haemolysis or severe anaemia
6 months
The incidence risk of symptomatic P. vivax parasitaemia within 4 months.
Time Frame: 4 months
The incidence risk (time to first event) of symptomatic P. vivax parasitaemia within 4 months as determined by microscopy.
4 months
Proportion of adverse events within 14 days.
Time Frame: 14 days
The number and proportion of adverse events within 14 days after start of treatment
14 days
The number and proportion of serious adverse events.
Time Frame: 6 Months
The number and proportion of serious adverse events.
6 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Menzies School of Health Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aga Khan University
University of Melbourne
Curtin University
Jimma University
Universitas Sumatera Utara
Papua New Guinea Institute of Medical Research
Arba Minch University
PathWest Laboratory Medicine WA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kamala Thriemer, Professor, Menzies School of Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRIMUS
  • GTN2042278 (Other Grant/Funding Number: NHMRC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data (IPD) underlying the results reported in this trial will be shared. This will include baseline characteristics, outcome measures, and adverse events data. Data will be available beginning [6-12 months] after publication of the primary results, and will be shared with qualified researchers upon reasonable request, following approval of a research proposal and completion of a data access agreement. Supporting documents such as the study protocol and statistical analysis plan will also be provided.

IPD Sharing Access Criteria

All the investigators involved in the study.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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