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Not yet recruiting NCT07468526

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

Phase III Interventional Malaria

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: High dose ultra short Primaquine, Placebo.
Who it may be relevant to
Registry conditions: Malaria. Basic parameters: from 5 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ethiopia, Indonesia, Pakistan, Papua New Guinea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Incidence risk of any recurrent vivax parasitaemia within 4 months. [Time frame: 4 Months]
Secondary outcome measures (8)
  • The incidence risk of any P. vivax parasitaemia within 6 months. [Time frame: 6 months]
  • Incidence of haemoglobin drop >25% to <7g/dl within 14 days of treatment. [Time frame: 0-14 days]
  • Incidence of moderate anaemia within 14 days after starting primaquine [Time frame: 0-14 days]
  • Incidence of severe anaemia within 14 days after starting Primaquine [Time frame: 0-14 days]
  • • The proportion of patients requiring blood transfusion within the 6 months follow up period. [Time frame: 6 months]
  • The incidence risk of symptomatic P. vivax parasitaemia within 4 months. [Time frame: 4 months]
  • Proportion of adverse events within 14 days. [Time frame: 14 days]
  • The number and proportion of serious adverse events. [Time frame: 6 Months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Ethiopia · 2 centers
  • Arba Minch University — Arba Minch
  • Jimma University — Jimma
Indonesia · 1 center
  • Universitas Sumatera — Bandar Lampung
Pakistan · 1 center
  • Aga Khan University, Karachi — Karachi
Papua New Guinea · 1 center
  • Papua New Guinea Institute of Medical Research — Port Moresby

Identifiers

NCT: NCT07468526 · PRIMUS · GTN2042278

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗