ChiCTR2400081468 版本V1.0 版本创建时间2024/03/01 15:22:53 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400081468 

最近更新日期：

Date of Last Refreshed on：

 2024-03-01 15:22:36 

注册时间：

Date of Registration：

 2024-03-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

季節性對耐甲氧西林金?色葡萄球菌(MRSA)引起的 皮膚和軟組織感染的影響

Public title：

The effect of seasonality on skin and soft tissue infection due to methicillin-resistant staphylococcus aureus (MRSA)

注册题目简写：

English Acronym：

研究课题的正式科学名称：

季節性對耐甲氧西林金?色葡萄球菌(MRSA)引起的 皮膚和軟組織感染的影響

Scientific title：

The effect of seasonality on skin and soft tissue infection due to methicillin-resistant staphylococcus aureus (MRSA)

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Ng Wai Yin 

研究负责人：

Ng Wai Yin 

Applicant：

Ng Wai Yin 

Study leader：

Ng Wai Yin 

申请注册联系人电话：

Applicant telephone：

 +852 3505 6959

研究负责人电话：

Study leader's
telephone：

+852 3505 6959

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 ritang@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 ritang@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

研究负责人通讯地址：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

Applicant address：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

Study leader's address：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2024.035

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-02-06 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Department of Microbiology/CUHK

Primary sponsor：

Department of Microbiology/CUHK

研究实施负责（组长）单位地址：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

Primary sponsor's address：

Department of Microbiology, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

Department of Microbiology/CUHK

具体地址：

Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories

Institution
hospital：

Department of Microbiology/CUHK

Address：

Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, New Territories

经费或物资来源：

Department of Microbiology/CUHK

Source(s) of funding：

Department of Microbiology/CUHK

研究疾病：

Skin and soft tissue infection  

Target disease：

Skin and soft tissue infection

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

析因分组（即根据危险因素或暴露因素分组） 

Study design：

Factorial 

研究目的：

1. To examine the correlation between skin and soft tissue infections in adult patients due to MRSA and environmental factors including average temperature and humidity in all Hong Kong hospitals in 2008-2019. 2. To examine the correlation between skin and soft tissue infections in paediatric and adult patients due to MRSA and MSSA and environmental factors including average temperature and humidity and its associated microbiological characteristics in a 2-year prospective multicentre study  

Objectives of Study：

1. To examine the correlation between skin and soft tissue infections in adult patients due to MRSA and environmental factors including average temperature and humidity in all Hong Kong hospitals in 2008-2019. 2. To examine the correlation between skin and soft tissue infections in paediatric and adult patients due to MRSA and MSSA and environmental factors including average temperature and humidity and its associated microbiological characteristics in a 2-year prospective multicentre study

药物成份或治疗方案详述：

Objective 1. The study is a retrospective study to delineate the association of seasonality with incidence of MRSA skin and soft tissue infection in adult patients for 11 year-period (2008) Objective 2. The study is a 24-month prospective observational study of 320 cases of skin and soft tissue infection in paediatric and adult patients caused by MRSA and MSSA in relation to seasonality.  

Description for medicine or protocol of treatment in detail：

 

纳入标准：

For Objective 1: Inclusion Criteria: Adult patients with diagnosis code of skin and soft tissue infection with microbiological evidence of MRSA isolated in wound swab, wound aspirate, tissue, pus or blood culture in CDARS in 2008-2019 For Objective 2 Inclusion Criteria: Paediatric and adult patients receiving clinical diagnosis of skin and soft tissue infection with microbiological evidence of MRSA or MSSA isolated in wound swab, wound aspirate, tissue, pus or blood culture

Inclusion criteria

For Objective 1: Inclusion Criteria: Adult patients with diagnosis code of skin and soft tissue infection with microbiological evidence of MRSA isolated in wound swab, wound aspirate, tissue, pus or blood culture in CDARS in 2008-2019 For Objective 2 Inclusion Criteria: Paediatric and adult patients receiving clinical diagnosis of skin and soft tissue infection with microbiological evidence of MRSA or MSSA isolated in wound swab, wound aspirate, tissue, pus or blood culture

排除标准：

For Objective 1: Exclusion Criteria: Patients without hospital mortality data from CDARS For Objective 2 Exclusion Criteria: Patients whose culture fail to yield MRSA or MSSA

Exclusion criteria：

For Objective 1: Exclusion Criteria: Patients without hospital mortality data from CDARS For Objective 2 Exclusion Criteria: Patients whose culture fail to yield MRSA or MSSA

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2027-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-03-01 00:00:00 至 To 2027-02-28 00:00:00

干预措施：

Interventions：

组别：

Group 1

样本量：

 7000

Group：

Group 1

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

组别：

Group 2

样本量：

 320

Group：

Group 2

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

Shatin

单位(医院)：

 威爾士親王醫院 

单位级别：

 三甲醫院 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

Epidemiological and clinical data of skin and soft tissue infection associated with meteorological variation

指标类型：

主要指标

Outcome：

Epidemiological and clinical data of skin and soft tissue infection associated with meteorological variation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Laboratory characterization of MRSA

指标类型：

主要指标

Outcome：

Laboratory characterization of MRSA

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

wound swab, wound aspirate, tissue, pus or blood culture

组织：

Sample Name：

wound swab, wound aspirate, tissue, pus or blood culture

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

Randomization Procedure (please state who generates the random number sequence and by what method)：

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

N/A

Blinding：

N/A

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

will be through publications and presentations at conferences relevant to the speciality. We aim to publish the findings in peer reviewed journals

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

will be through publications and presentations at conferences relevant to the speciality. We aim to publish the findings in peer reviewed journals

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

All data management will be undertaken by the Prince of Wales Hospital. Standard operating procedures will be in place for the collection and handling of data received at the Unit. All study data will be entered into a secure electronic trial database with restricted access. Data collected on the data collection forms and entered into the electronic database will only identify the participants by a unique trial number

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

All data management will be undertaken by the Prince of Wales Hospital. Standard operating procedures will be in place for the collection and handling of data received at the Unit. All study data will be entered into a secure electronic trial database with restricted access. Data collected on the data collection forms and entered into the electronic database will only identify the participants by a unique trial number

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-03-01 15:22:36