Clinical trial NCT02094638: Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study
Official title: Post-Marketing Surveillance of the Tanreqing Injection: a Real World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adverse Drug Reaction
Drug Allergy
Keywords: Traditional Chinese Medicine Injection
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Kaibao Pharmaceutical CO.,LTD.
name: Peking University
name: Handan First Hospital
name: Bethune International Peace Hospital of the Chinese PLA
name: The 254th Hospital of chinese People's Liberation Army
name: The 464th Hospital of chinese People's Liberation Army
name: People's Hospital of Cangzhou
name: The First Hospital of Qinhuangdao
name: The 44th Hospital of chinese People's Liberation Army
name: First Affiliated Hospital of Kunming Medical University
name: The Second Affiliated Hospital of Kunming Medical University
name: Chongqing Three Gorges Central Hospital
name: Sichuan Provincial People's Hospital
name: ShuangLiu Hospital of Traditional Chinese Medical
name: People's Hospital of Nanbu County
name: DuJiangyan Traditional Chinese Medicine Hospital
name: West China Hospital
name: Chongqing Traditional Chinese Medicine Hospital
name: The Third People's Hospital of Chongqing
name: Changsha Fourth Hospital
name: Hubei Xinhua Hospital
name: Wenzhou Central Hospital
name: Affiliated Yueqing Hospital of Wenzhou Medical University
name: The First Affiliated Hospital of Nanchang University
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai Minhang District Central Hospital
name: Shanghai First People's Hospital Branch
name: Zhejiang Provincial Hospital of TCM
name: The Affiliated Hospital of Hainan medical College
name: Guiyang Children's Hospital
name: Traditional Chinese Medical Hospital of Jiangxi Province
name: Jiangxi Provincial People's Hopital
name: Hubei Cancer Hospital
name: Jiangning District Hospital of Traditional Chinese Medicine
name: Shenzhen Third People's Hospital
name: Ningbo No. 1 Hospital
name: Second Hospital of Jilin University
name: The First Hospital of Jilin University
name: Yangzhou No.1 People's Hospital
name: Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
name: Bijie First Municipal People's Hospital
name: Guiyang Pulmonary Hospital
name: The 263rd Hospital of Chinese People's Liberation Army
name: Chongqing Kaixian County People's Hospital
name: The Second Affiliated Hospital of Chongqing Medical University
name: Chongqing Jiulongpo First People's Hospital
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: Shenyang 242 Hospital
name: Second Affiliated Hospital of Guangzhou Medical University
name: Cancer Hospital of Guizhou Province
name: Wu Song Central Hospital of Shanghai
name: Gansu Provincial Hospital
name: Lanzhou Petrochemical General Hospital
name: Traditional Chinese Medicine Hospital of the Ningxia Hui Autonomous Region
name: General Hospital of Ningxia Medical University
name: The First People's Hospital of Yinchuan
name: Yantai Municipal Laiyang Central Hospital
name: Shandong Cancer Hospital and Institute
name: Shandong University of Traditional Chinese Medicine
name: Zunyi Medical College
name: The 152nd Hospital of chinese People's Liberation Army
name: Henan Provincial People's Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Central South University
name: The Second Hospital of Nanchang
name: The Second Hospital of Wulanchabu City
name: Qinghai Women and Childhood Hospital
name: The Third People's Hospital of Chengdu
name: The Center Hospital of Shuozhou
name: Yunnan Provinical Hospital of Traditional Chinese Medicine
name: Beijing Geriatric Hospital
name: Hubei Zhongshan Hospital Affiliated to Wuhan University
name: Anhui Provincial Children's Hospital
name: The Third Affiliated Hospital of Inner Mongolia Medical College
name: The fourth Hospital of Inner Mongolia
name: Zhongshan People's Hospital, Guangdong, China
name: Fenyang Hospital of Shanxi Province
name: The First Hospital Of Huhhot
name: Taiyuan Xinghualing Maternity & Child Health Care Center
name: The Fifth People's Hospital of Datong
name: Shanxi Provincial Maternity and Children's Hospital
name: The Second People's Hospital of Jinzhong
name: The Second Hospital of Hebei Medical University
name: People's Hospital of Rongcheng
name: Hebei Zhaoxian People's Hospital
name: Hejian Municipal People's Hospital
name: Xinle Municipal Hospital of Hebei
name: Capital Medical University
name: Fengtai district Hospital of Chinese and Western medicine, Beijing
name: Shanghai Changzheng Hospital
name: Xintai People's Hospital
First posted: 2014-03-24
Enrollment: 30400
Sex: ALL
Minimum age (years): 24
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who use the Tanreqing Injection in selected hospitals in China (including the inpatient and the outpatient(only in some hospitals which can get the information)).

Brief summary: Tanreqing Injection is widely used in respiratory disease with Chinese medicine syndrome of retention of phlegm and heat in Fei. This study record clinical use of Tanreqing Injection in the real world, observe the adverse drug reactions/ adverse drug events during treatment, and figure out why Tanreqing induced severe allergic reaction happens.

Detailed description: As a compound traditional Chinese medicine, Tanreqing Injection was approved by China Food and Drug Administration(CFDA) in 2003, and widely used respiratory disease, such as biofilm related upper respiratory infections, pneumonia and bronchitis. During its 11 years marketing in China, there was hardly any serious adverse drug reactions except for a few cases reported as severe allergic reaction. In this study, clinical pharmacists in selected hospitals will not only record the clinical use and the adverse drug reactions/ adverse drug events of this injection, but also try to figure out why drug-induced severe allergic reaction happens through a nested case-control study. This real world study for Tanreqing Injection with 30400 patients will be conducted from January.2014 to June.2016.

Eligibility criteria: Inclusion Criteria:

* Patients who use the Tanreqing Injection in selected hospitals in China, including inpatient and outpatient.
* Outpatients will be only in some hospitals which can get the patients' complete information.

Exclusion Criteria:

* Patients who are less than 24 months.

Primary outcomes:
measure: Incidence of adverse drug reaction of Tanreqing Injection
timeFrame: 30 months
Secondary outcomes:
measure: Outcomes of the patients who experienced an adverse drug reaction of Tanreqing Injection
timeFrame: 30 months
measure: Administration of Tanreqing Injection in real world
timeFrame: 30 months
measure: Population characteristics of the adverse drug reaction of Tanreqing Injection
timeFrame: 30 months
measure: Off-lable use of Tanreqing Injection
timeFrame: 30 months
measure: Drug combination of Tanreqing Injection in real world
timeFrame: 30 months
Other outcomes:
measure: Related Risk Factors in severe allergic reaction of Tanreqing Injection
timeFrame: 30 months
Locations:
city: Hefei
country: China
facility: Anhui Provincial Children's Hospital
state: Anhui
city: Beijing
country: China
facility: The Fengtai district Hospital of Integrated TCM & WM
state: Beijing
city: Beijing
country: China
facility: Beijing Geriatric Hospital
state: Beijing
city: Beijing
country: China
facility: The 263rd Hospital of Chinese People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Beijing Luhe Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Chongqing
country: China
facility: The Third People's Hospital of Chongqing
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Traditional Chinese Medicine Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Jiulongpo First People's Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Three Gorges Central Hospital
state: Chongqing
city: Chongqing
country: China
facility: Chongqing Kaixian County People's Hospital
state: Chongqing
city: Lanzhou
country: China
facility: Gansu Provincial Hospital of Traditional Chinese Medicine
state: Gansu
city: Lanzhou
country: China
facility: Lanzhou Petrochemical General Hospital
state: Gansu
city: Huizhou
country: China
facility: The Third People's Hospital of Huizhou
state: Guangdong
city: Shenzhen
country: China
facility: The Third People's Hospital of Shenzhen
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan Municipal People's Hospital
state: Guangdong
city: Bijie
country: China
facility: Bijie First Municipal People's Hospital
state: Guizhou
city: Guiyang
country: China
facility: Guiyang Children's Hospital
state: Guizhou
city: Guiyang
country: China
facility: Guiyang Pulmonary Hospital
state: Guizhou
city: Guiyang
country: China
facility: Guizhou Cancer Hospital
state: Guizhou
city: Guiyang
country: China
facility: The 44th Hospital of chinese People's Liberation Army
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical College
state: Guizhou
city: Haikou
country: China
facility: The Affiliated Hospital of Hainan medical College
state: Hainan
city: Baoding
country: China
facility: People's Hospital of Rongcheng
state: Hebei
city: Cangzhou
country: China
facility: People's Hospital of Cangzhou
state: Hebei
city: Handan
country: China
facility: First Hospital of Handan City
state: Hebei
city: Hejian
country: China
facility: Hejian Municipal People's Hospital
state: Hebei
city: Qinhuangdao
country: China
facility: The First Hospital of Qinhuangdao
state: Hebei
city: Shijiazhuang
country: China
facility: the Second Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang
country: China
facility: Bethune International Peace Hospital of the Chinese PLA
state: Hebei
city: Shijiazhuang
country: China
facility: Hebei Zhaoxian People's Hospital
state: Hebei
city: Xinle
country: China
facility: Xinle Municipal Hospital of Hebei
state: Hebei
city: Pingdingshan
country: China
facility: The 152nd Hospital of chinese People's Liberation Army
state: Henan
city: Zhengzhou
country: China
facility: Henan Province Hospital of TCM
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Hubei Xinhua Hospital
state: Hubei
city: Wuhan
country: China
facility: Hubei Zhongshan Hospital Affiliated to Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changsha
country: China
facility: The Fourth Hospital of Changsha
state: Hunan
city: Changsha
country: China
facility: the Second Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The Third Affiliated Hospital of Inner Mongolia Medical College
state: Inner Mongolia
city: Huhehaote
country: China
facility: The First Hospital Of Huhhot
state: Inner Mongolia
city: Huhehaote
country: China
facility: The fourth Hospital of Inner Mongolia
state: Inner Mongolia
city: Wulanchabu
country: China
facility: The Second Hospital of Wulanchabu City
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangning District Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Yangzhou
country: China
facility: The First People's Hospital of Yangzhou City
state: Jiangsu
city: Nanchang
country: China
facility: The Second Hospital of Nanchang
state: Jiangxi
city: Nanchang
country: China
facility: Jiangxi Provincial People's Hospital
state: Jiangxi
city: Nanchang
country: China
facility: Traditional Chinese Medical Hospital of Jiangxi Province
state: Jiangxi
city: Nanchang
country: China
facility: The First Hospital of Nanchang
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Shenyang 242 Hospital
state: Liaoning
city: Yinchuan
country: China
facility: The First People's Hospital of Yinchuan
state: Ningxia
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Yinchuan
country: China
facility: Chinese Traditional Medicine Hospital of Ningxia Autonomous Region
state: Ningxia
city: Xining
country: China
facility: Qinghai Women and Childhood Hospital
state: Qinghai
city: Jinan
country: China
facility: Affiliated Hospital of Shandong University of Traditional Chinese Medicine
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Xintai
country: China
facility: Xintai People's Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai Municipal Laiyang Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First People's Hospital Branch
state: Shanghai
city: Shanghai
country: China
facility: Wu Song Central Hospital of Shanghai
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Minhang District Central Hospital
state: Shanghai
city: Datong
country: China
facility: Fifth Hospital of Datong
state: Shanxi
city: Fenyang
country: China
facility: Fenyang Hospital of Shanxi Province
state: Shanxi
city: Jinzhong
country: China
facility: The Second People's Hospital of Jinzhong
state: Shanxi
city: Shuozhou
country: China
facility: The Center Hospital of Shuozhou
state: Shanxi
city: Taiyuan
country: China
facility: Maternal and Child Health Care Hospital of Taiyuan
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Maternity and Children Health Hospital
state: Shanxi
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu
state: Sichuan
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: ShuangLiu Hospital of Traditional Chinese Medical
state: Sichuan
city: Dujiangyan
country: China
facility: DuJiangyan Traditional Chinese Medicine Hospital
state: Sichuan
city: Nanchong
country: China
facility: People's Hospital of Nanbu County
state: Sichuan
city: Tianjin
country: China
facility: The 254th Hospital of chinese People's Liberation Army
state: Tianjin
city: Tianjin
country: China
facility: The 464th Hospital of chinese People's Liberation Army
state: Tianjin
city: Wulumuqi
country: China
facility: People's Hospital of Xinjiang Uigur Autonomous Region
state: Xinjiang
city: Dali
country: China
facility: Traditional Chinese Medical Hospital of Bai Autonomous Prefecture of Dali
state: Yunnan
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: Second Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: Zhejiang Provincial Hospital of TCM
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Yueqing People's Hospital
state: Zhejiang
city: Beijing
country: China
facility: Peking university third hospital
Study officials:
References: