今天是:2020-04-08 星期三

抗弓形虫方案治疗艾滋病合并弓形虫脑病患者疗效与安全性的多中心前瞻性随机对照研究
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注册号:

Registration number:

ChiCTR2000031277 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

抗弓形虫方案治疗艾滋病合并弓形虫脑病患者疗效与安全性的多中心前瞻性随机对照研究 

Public title:

Efficacy and safety of anti-Toxoplasma treatment regimens for AIDS-infected patients: study protocol of a multi-center prospective randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

五种高致死(残)性艾滋病机会性感染及难治性艾滋病的精准诊治策略研究  

Scientific title:

A study for precision diagnosing and treatment strategies in difficult-to-treat AIDS cases and HIV-infected patients with highly fatal or highly disabling opportunistic infections  

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:

李瑶 

研究负责人:

陈耀凯 

Applicant:

Yao Li 

Study leader:

Yao Kaichen 

申请注册联系人电话:

Applicant telephone:

+86 18983763573 

研究负责人电话:

Study leader's telephone:

+86 13838352995 

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:

yaoli0823@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

yaokaichen@hotmail.com 

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:

重庆市沙坪坝区保育路109号 

研究负责人通讯地址:

重庆市沙坪坝区保育路109号 

Applicant address:

109 Baoyu Road, Shapingba, Chongqing, China 

Study leader's address:

109 Baoyu Road, Shapingba, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400036 

研究负责人邮政编码:

Study leader's postcode:

400036 

申请人所在单位:

重庆市公共卫生医疗救治中心 

Applicant's institution:

Chongqing Public Health Medical Center 

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:

2019-003-01-KY 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

重庆市公共卫生医疗救治中心伦理委员会 

Name of the ethic committee:

The Institution Review Board of Chongqing Public Health Medical Center  

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-18 

伦理委员会联系人:

陈亚玲 

Contact Name of the ethic committee:

Yaling Chen 

伦理委员会联系地址:

重庆市沙坪坝区保育路109号 

Contact Address of the ethic committee:

109 Baoyu Road, Shapingba, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

重庆市公共卫生医疗救治中心 

Primary sponsor:

Chongqing Public Health Medical Center 

研究实施负责(组长)单位地址:

重庆市沙坪坝区保育路109号 

Primary sponsor's address:

109 Baoyu Road, Shapingba, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

ChongQing

City:

单位(医院):

重庆市公共卫生医疗救治中心

具体地址:

重庆市沙坪坝区保育路109号

Institution
hospital:

Chongqing Public Health Medical Center

Address:

109 Baoyu Road, Shapingba, Chongqing

经费或物资来源:

十三五科技重大专项 

Source(s) of funding:

The National Science and Technology Major of China of the 13th Five-Year Plan  

研究疾病:

艾滋病合并弓形虫脑炎 

Target disease:

AIDS-associated toxoplasma encephalitis  

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

在大样本回顾性病例研究和前瞻性队列基础上,系统性开展艾滋病合并弓形虫脑病分型分期诊断研究;并通过开展规范的大样本前瞻性队列研究,研究艾滋病合并弓形虫脑病诊断治疗新方案。 

Objectives of Study:

This study aims to investigate the efficacy and safety of synergistic sulfonamides, in combination with clindamycin, in patients with AIDS-associated toxoplasma encephalitis, by comparing outcomes with that of TMP-SMX plus azithromycin, a guidelines-recommended alternative anti-toxoplasma regimen. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)年龄≥18岁,男女不限; (2)ELISA检测HIV-1抗体阳性和HIV补充试验阳性(Western Blot试验阳性或核酸定性检测阳性或核酸定量大于5000拷贝/ml); (3)临床诊断为弓形虫脑病; (4)自愿签署受试者知情同意书,并愿意接受随访; (5)研究者认为,受试者总体状况不影响试验的评估和完成。 

Inclusion criteria

Patients will be included in our study if they meet the following criteria: (1) Aged 18 years or older; (2) Confirmed diagnosis of AIDS-associated toxoplasma encephalitis; (3) Willing to sign the informed consent. 

排除标准:

(1)对相关治疗药物严重过敏或不能耐受者; (2)入选时检测到下列结果:血红蛋白<60g/L、白细胞计数<1.0×109 /L、中性粒细胞数<0.5×109 /L、血小板计数<50×109 /L、血淀粉酶>2倍参考水平上限、血肌酐>1.5倍参考水平上限、天门冬氨酸氨基转移酶/丙氨酸氨基转移酶/碱性磷酸酶>5倍参考水平上限、总胆红素>2倍参考水平上限、血清肌酸磷酸肌酶(CK)>2倍参考水平上限; (3)合并其他疾病影响疗效及预后者; (4)合并其他机会性感染且病情不稳定者; (5)有严重心、脑、肺、肾、肿瘤等基础疾病; (6)妊娠期、哺乳期的妇女; (7)有严重精神性疾病的患者; (8)静脉吸毒者; (9)非中国国籍人员。 

Exclusion criteria:

Patients will be excluded from our study if they have the following: (1) Allergic or intolerant to therapeutic medications; (2) Hemoglobin (Hb) <60g/L, white blood cell count (WBC) <1.0x10^9/L, neutrophil count (N) <0.5x10^9/L, platelet count (PLT) <50x10^9/L, blood amylase (AMS) >2 UNL, serum creatinine (Scr) >1.5 UNL, aspartate aminotransferase (AST) /alanine aminotransferase (ALT) /alkaline phosphatase (ALP) >5 UNL, total bilirubin (TB) >2 UNL, serum creatine phosphokinase (CK) >2 UNL; (3) Unstable severe concomitant diseases, opportunistic infections other than toxoplasmic encephalitis, or mental illnesses that may affect efficacy assessment or compliance; (4) Pregnant or breastfeeding women; (5) Intravenous recreational drug use; (6) Non-Chinese nationality.  

研究实施时间:

Study execute time:

From2019-02-01To 2020-12-31 

干预措施:

Interventions:

组别:

A组

样本量:

200

Group:

Group A

Sample size:

干预措施:

复方新诺明1.44g q8h口服,联合阿奇霉素0.5 g qd静脉给药,疗程至少6周

干预措施代码:

Intervention:

TMP-SMX (oral dose of 1.44g, every 8 hours) plus azithromycin (intravenous dose of 0.5g, once a day), for at least 6 weeks

Intervention code:

组别:

B组

样本量:

100

Group:

Group B

Sample size:

干预措施:

增效联磺1.44g q8h口服,联合克林霉素 600 mg q6h静脉给药,疗程至少6周

干预措施代码:

Intervention:

Synergistic sulfonamides (oral dose of 1.44g, every 8 hours) plus clindamycin (intravenous dose of 0.6 g, every 6 hours), for at least 6 weeks.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

重庆市公共卫生医疗救治中心 

单位级别:

三级 

Institution
hospital:

Chongqing Public health medical center  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

重庆 

市(区县):

 

Country:

China 

Province:

Chongqing 

City:

 

单位(医院):

长沙市第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Hospital of Changsha  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京佑安医院 

单位级别:

三甲医院 

Institution
hospital:

Beijing Youan Hospital, Capital Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

 

Country:

China 

Province:

Helongjiang 

City:

 

单位(医院):

哈尔滨医科大学 

单位级别:

三甲医院 

Institution
hospital:

Harbin Medical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广州市第八人民医院 

单位级别:

三级医院 

Institution
hospital:

The Eighth People's Hospital of Guangzhou  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

柳州市人民医院 

单位级别:

三甲医院 

Institution
hospital:

Liuzhou General Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

桂林市第三人民医院 

单位级别:

二甲医院 

Institution
hospital:

The Third People's Hospital of Guilin  

Level of the institution:

Second A Hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

 

Country:

China 

Province:

Jilin 

City:

 

单位(医院):

吉林大学 

单位级别:

大学 

Institution
hospital:

Jilin University  

Level of the institution:

University 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

云南省传染病专科医院(艾滋病关爱中心) 

单位级别:

三级甲等 

Institution
hospital:

Yunnan Provincial Infectious Disease Hospital, also named Yunnan AIDS Care Center  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

贵州 

市(区县):

 

Country:

China 

Province:

Guizhou 

City:

 

单位(医院):

贵阳市公共卫生救治中心 

单位级别:

三级 

Institution
hospital:

the Third People's Hospital of Shenzhen  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

深圳市第三人民医院 

单位级别:

三级甲等 

Institution
hospital:

the Third People's Hospital of Shenzhen  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

昆明市第三人民医院 

单位级别:

三级甲等 

Institution
hospital:

Kunming Third People's Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

广西壮族自治区龙潭医院 

单位级别:

三级甲等 

Institution
hospital:

Longtan Hospital of Guangxi Zhuang Autonomous Region  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广西壮族自治区 

市(区县):

 

Country:

China 

Province:

Guangxi Zhuang Autonomous Region 

City:

 

单位(医院):

南宁市第四人民医院 

单位级别:

三级甲等 

Institution
hospital:

the Fourth People's Hospital of Nanning  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

成都市公共卫生临床医疗中心 

单位级别:

三级甲等 

Institution
hospital:

Public Health Clinical Center of Chengdu  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

杭州市西溪医院 

单位级别:

三级甲等 

Institution
hospital:

Xixi Hospital of Hangzhou  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学 

单位级别:

大学 

Institution
hospital:

Zhejiang University  

Level of the institution:

University 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津市第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Second People's Hospital of Tianjin  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

临床反应率

指标类型:

主要指标 

Outcome:

clinical response rate

Type:

Primary indicator 

测量时间点:

6周

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全因死亡率

指标类型:

主要指标 

Outcome:

all-cause mortality

Type:

Primary indicator 

测量时间点:

6周

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床反应率

指标类型:

次要指标 

Outcome:

clinical response rate

Type:

Secondary indicator 

测量时间点:

48周

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全因死亡率

指标类型:

次要指标 

Outcome:

all-cause mortality

Type:

Secondary indicator 

测量时间点:

48周

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良反应

指标类型:

次要指标 

Outcome:

adverse events

Type:

Secondary indicator 

测量时间点:

每个访视点

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:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

脑脊液

组织:

Sample Name:

cerebrospinal fluid

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

通过医学研究平台(http://www.51yyt.org/FrontPage/Index.aspx)将受试者随机分配到两组中

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

A specific random number sequence will be generated by Medical Research Platform (http://www.51yyt.org/FrontPage/login.aspx?Inviter=) for each patient with consent, and will be used to randomly assign patients into the TMP-SMX plus azithromycin group, or the synergistic sulfonamides plus clindamycin group at a 1:1 ratio.

盲法:

开放

Blinding:

open label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

研究完成后,我们将通过发表的医学期刊文章和会议报告分享研究结果;ResMan, http://www.medresman.org.cn。

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

We will share the results through published medical journal articles and at conference presentation after completion of the study; ResMan, http://www.medresman.org.cn.

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:

所有数据将记录在病例报告表(CRF)上,并通过医学研究平台立即记录在数据库中。

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

All data will be documented on case report forms (CRFs) and immediately recorded in the database through the Medical Research Platform.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-03-26
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