PREDICATE Trial

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Early Prednisolone for Suspected Community-acquired Acute Respiratory Tract Infection (PREDICATE): A Double-blind, Randomised, Multi-centre, Adaptive Platform, Controlled Trial

Research purpose:

To evaluate treatment with oral prednisolone started in the Emergency Departments (EDs) for adult participants with suspected community-acquired acute respiratory infections (scARI) who have planned hospitalisation.

 

The main question: 

In adult patients with suspected community-acquired acute respiratory tract infection attending emergency departments and planned hospitalisation does Active Treatment + Usual care (UC) versus Placebo +UC reduce the risk of sepsis or mortality within 30 days from randomisation?

 

Key facts:

  • Setting: In the EDs or wards of Princess Margaret Hospital and two university-affiliated Hospital Authority hospitals in Hong Kong and will be 24/7
  • Participants: The trial aims to recruit 1300 adult patients (650 in each arm)
  • Interventions: Placebo vs Active Treatment (tablets are administered once per day for five days + Usual Care)

 

Duration:

1st August 2024 – 31st July 2027 (36 months)

 

 

*The English version shall prevail in case of any discrepancy or inconsistency between the English version and its Chinese translation.

 

早期潑尼松龍(Prednisolone)於急性呼吸系統感染疾病的應用(PREDICATE)雙盲,隨機,對照試驗

 

研究目的:

評估對疑似急性呼吸系統感染疾病並會安排入院治療的病人於急症室開始口服潑尼松龍(Prednisolone)之療效。

 

研究問題:

在前往急症室併計劃住院的疑似社區獲得急性呼吸系統感染疾病成年患者中,主動治療+ 常規護理與安慰劑+常規護理相比,是否可以降低隨機分組後30天內敗血症或死亡的風險?

 

關鍵:
  • 地點:香港醫院管理局醫院的三間急診室 – 瑪麗醫院 (QMH)、瑪嘉烈醫院 (PMH) 和威爾斯親王醫院 (PWH) 
  • 參與者:試驗旨在招募 1300 名成年患者(每組 650 名)
  • 治療介入:安慰劑與主動治療(每天一次藥片,持續五天+常規護理)

 

研究為期:

2024年8月1日至2027年7月31日(36個月)

 

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*此中文版本為英文版本譯本,如中、英文兩個版本有任何抵觸或不相符之處,應以英文版本為準。