Multicentre, Randomized, Controlled Clinical Trial Comparing Oseltamivir With Placebo And Zanamivir With Control As The First Line Treatment For Human Swine Influenza (H1N1) Infection In Designated Flu Clinics During The Pandemic Influenza in Hong Kong
The Centre for Clinical Trials, CUHK has coordinated with the Food and Health Bureau and Hospital Authority on a clinical trial for Influenza A (H1N1) Infection in Hong Kong. The outbreak of the respiratory illnesses in Mexico that began in March 2009 was caused by a swine origin influenza A (H1N1) virus (S-OIV) that had not been recognized previously in pigs or humans. As of 17 May 2009, 39 countries have officially reported 8480 cases of influenza A (H1N1) infection.
The H1N1 influenza A virus appears sensitive to oseltamivir and zanamivir in vitro, but resistant to amantadine and rimantadine. This clinical study is to test the oseltamivir, zanamivir and placebo as the first line treatment for human swine influenza infection. Through the study, we may have better understanding about the clinical, biochemical and virological profiles of oseltamivir/zanamivir on the H1N1 virus, and optimizing the treatment methodology in Hong Kong.
The clinical study would be conducted in selected designated flu clinics in Hong Kong, including the Fanling Family Medicine Centre, Sai Ying Pun Jockey Club General Outpatient Clinic and Shau Kei Wan Jockey Club Clinic. The study initiation visits for Fanling Family Medicine Centre and Sai Ying Pun Jockey Club General Outpatient Clinic have been conducted on 14th October 2009 and 16 November 2009 respectively.
The Centre for Clinical Trials would coordinate with the three study sites for the study procedures and logistics and provide manpower and other research supplies. All three sties would be well prepared for the study and patient recruitment. We hope to complete the patient recruitment process in the next flu season.
一個比較奧司他韋（Oseltamivir）與安慰劑，以及扎那米韋（Zanamivir）與其對照作為第一線治療人類豬流感（ H1N1病毒）感染藥物，於流感大流行期間在香港的指定門診進行的多中心，隨機，對照的臨床試驗
香港中文大學臨床試驗中心最近聯同食物及衛生局和香港醫院管理局，合作展開了一項有關甲型流感（H1N1）感染的臨床試驗。這個呼吸系統疾病於 2009年3月在墨西哥開始暴發，致病的原因其後發現為源於豬隻的甲型流感（H1N1）病毒﹝簡稱S-OIV﹞，此病毒之前未曾於人類或豬隻身上發現過。 截至2009年5月17日，已經有39個國家合共報告了8480個甲型流感（H1N1）感染的病例。
體外研究顯示奧斯他韋和扎那米韋對甲型流感病毒（H1N1）有抑制作用，但金剛烷胺和金剛乙胺則作用不大。這項臨床試驗用以研究奧司他韋，扎那米韋 和安慰劑作為第一線治療人類豬型流感藥物的療效。通過這項研究，我們預期可以掌握更多有關奧司他韋和扎那米韋對甲型流感（H1N1）病毒的臨床、生化和病 毒學的作用，從而優化對此疾病的治療方法。
這項臨床研究會於指定的流感診所進行，當中包括粉嶺家庭健康中心，西營盤賽馬會普通科門診診所，以及筲箕灣賽馬會診所。粉嶺家庭健康中心和西營盤賽馬會普通科門診診所的試驗起始訪視已分別於2009年10月14日及2009年11月16日完成。
臨床試驗中心會協調各個研究基地的試驗工作及流程，並提供適當的人力和其他研究資源，以協助基地的研究工作，使這三個研究基地對試驗的運作及病人招聘等都有更深入的認識。在下一個流感季節或會有很多甲型流感（H1N1）的病例，我們期望在這流感高峰期完成足夠的病人招聘。