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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.
• Другое 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).

Первичные конечные точки

• Incidence risk of any recurrent vivax parasitaemia within 4 months. [Срок оценки: 4 Months]

Вторичные конечные точки (8)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Ethiopia · 2 центра

• Arba Minch University — Arba Minch
• Jimma University — Jimma

Индонезия · 1 центр

• Universitas Sumatera — Bandar Lampung

Пакистан · 1 центр

• Aga Khan University, Karachi — Karachi

Papua New Guinea · 1 центр

• Papua New Guinea Institute of Medical Research — Port Moresby

Идентификаторы

NCT: NCT07468526 · PRIMUS · GTN2042278

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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