About this Project 關於這個研究
請點這裡查看中文版本。Please click here for Chinese version.
Background:
Acute Respiratory Infections are a leading cause of death worldwide and in Hong Kong. The World Health Organisation (WHO) has recommended that the search for effective and safe treatments through randomised controlled trials be pursued. There is a need evidence for a safe role for early treatments in patients with suspected community-acquired acute respiratory tract infections (scARIs) to reduce progression to sepsis, mortality and other outcomes.
Objectives:
In adults attending emergency departments (EDs) with scARI and planned hospitalisation, to determine the effect of active treatments to reduce the risk of sepsis or mortality within 30 days; and to determine the safety of treatments.
Hypothesis:
In adults with suspected community-acquired infection (scARI) and planned hospitalisation receiving usual care (UC), there is a significant reduction in the proportion of patients with sepsis or who die within 30 days after initiating active treatments compared with placebo, and no significant increase in serious adverse events (SAEs).
Design:
An investigator-initiated, parallel, double-blind, randomised, multi-centre, adaptive platform-controlled trial.
Outcomes:
The Trial has two co-primary outcomes:
1. the proportion of patients with either sepsis or mortality, censored at 30 days from the time of randomisation;
2. safety (defined as the proportion of patients with an SAE), censored at 30 days from the time of randomisation.
Key secondary outcomes include WHO Clinical Progression Scale (CPS); mortality; sepsis; length of hospital stay; cost-effectiveness; patient satisfaction.
Why do we do this research:
- Benefit to Healthcare/Expected results: Study interventions prevent the progression of sepsis, improve survival, safely reduce the duration of hospital admission, and hasten time to recovery. Prednisolone safely reduces sepsis and mortality from 25% to 18%.
- Benefits to Hong Kong and Worldwide: Active treatments (e.g. prednisolone are cheap, HK$0.2 per 5mg tablet) are widely available across the world. Any reduction of progression to sepsis and death if applied worldwide would improve the lives of millions of patients and save millions of dollars of healthcare costs.
*The English version shall prevail in case of any discrepancy or inconsistency between the English version and its Chinese translation.
關於這個研究
背景:
急性呼吸道感染是全球及香港的主要死亡原因之一。 世界衛生組織建議透過隨機對照試驗尋找有效且安全的治療方法。 利用證據證明早期治療對疑似社區型急性呼吸道感染患者的安全作用，以減少敗血症進展、死亡率和其他結果。
目標:
對於因疑似社區獲得急性呼吸系統感染疾病前往急診室並計劃住院治療的成人，以確定主動治療的效果，以降低 30 天內敗血症或死亡風險；並確定治療的安全性。
假設：
在疑似社區獲得性感染併計劃住院並接受常規護理的成人中，與安慰劑相比，開始主動治療後30天內，敗血症患者或死亡的患者比例顯著降低，並無顯著差異嚴重不良事件增加。
設計：
由研究員發起的、平行、雙盲、隨機、多中心、自適應平台對照試驗。
結果：
本試驗有兩個共同主要結果：
1. 敗血症或死亡患者的比例，在隨機分組後 30天進行審查；
2. 安全性（定義為有嚴重不良反應事件的患者比例), 在隨機分組30天後進行審查。
主要次要結果包括世界衛生組織臨床進展量表; 死亡; 敗血症; 住院時間; 成本效益; 患者滿意度。
為什麼要做這個研究：
- 對醫療保健的益處/預期結果：研究措施可預防敗血症的進展，提高生存率，安全地縮短住院時間，並加快康復時間。 潑尼松龍可安全地將敗血症和死亡率從 25% 降低至 18%。
- 對香港和世界各地的好處：主動的治療方法（例如便宜的潑尼松龍，每 5 毫克片劑 0.2 港元）在世界各地廣泛使用。 如果在全球範圍內應用，任何減少敗血症進展和死亡的方法都將改善數百萬患者的生活，並節省數百萬元的醫療費用。
*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。
