今天是:2019-12-13 星期五

青蒿素-哌喹片和蒿甲醚-本芴醇治疗无并发症恶性疟的随机单盲、多中心临床研究
下载XML文档

注册号:

Registration number:

ChiCTR1900025860 

最近更新日期:

Date of Last Refreshed on:

2019-09-11 

注册时间:

Date of Registration:

2019-09-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

青蒿素-哌喹片和蒿甲醚-本芴醇治疗无并发症恶性疟的随机单盲、多中心临床研究 

Public title:

A Randomized, Single-blind, Multi-center Clinical Study for Artemisinin-Piperazine and Artemether-Benzolol in the Treatment of Uncomplicated Falciparum Malaria 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

青蒿素-哌喹片和蒿甲醚-本芴醇治疗无并发症恶性疟的随机单盲、多中心临床研究 

Scientific title:

A Randomized, Single-blind, Multi-center Clinical Study for Artemisinin-Piperazine and Artemether-Benzolol in the Treatment of Uncomplicated Falciparum Malaria 

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:

张红英 

研究负责人:

宋健平 

Applicant:

Zhang Hongying 

Study leader:

Song Jianping 

申请注册联系人电话:

Applicant telephone:

+86 020 36618375 

研究负责人电话:

Study leader's telephone:

+86 020 36585633 

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:

zhhy0919@163.com 

研究负责人电子邮件:

Study leader's E-mail:

songjp@gzucm.edu.cn 

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:

广州市白云区太和镇永兴村陈太公路436号 

研究负责人通讯地址:

广州市白云区机场路12号实验楼509室 

Applicant address:

436 Chentai Road, Yongxing Village, Taihe Town, Baiyun District, Guangzhou  

Study leader's address:

Room 509, Laboratory Building, 12 Jichang Road, Baiyun District, Guangzhou 

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:

广州中医药大学 

Applicant's institution:

Guangzhou University of Chinese Medicine 

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:

BF2019-122-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-23 

伦理委员会联系人:

李晓彦 

Contact Name of the ethic committee:

Li Xiaoyan 

伦理委员会联系地址:

广东省广州市大德路111号 

Contact Address of the ethic committee:

111 Dade Road, Guangzhou, Guangdong  

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020-81887233&35943 

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:

广州中医药大学 

Primary sponsor:

Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

广州市白云区机场路12号 

Primary sponsor's address:

12 Jichang Road, Baiyun District, Guangzhou 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

马拉维共和国

省(直辖市):

利隆圭

市(区县):

Country:

Republic of Malawi

Province:

Lilongwe

City:

单位(医院):

Kamuzu中央医院

具体地址:

lilongwe

Institution
hospital:

Kamuzu Central Hospital

Address:

lilongwe

国家:

科摩罗联盟

省(直辖市):

大科摩罗岛

市(区县):

Country:

Union of Comoros

Province:

Grande Comore

City:

单位(医院):

MBENI区医疗中心

具体地址:

MBENI区

Institution
hospital:

MBENI District Medical Center

Address:

MBENI District

国家:

科摩罗联盟

省(直辖市):

大科摩罗岛

市(区县):

Country:

Union of Comoros

Province:

Grande Comore

City:

单位(医院):

MIZTSAMIOULI区

具体地址:

MIZTSAMIOULI区

Institution
hospital:

MIZTSAMIOULI district Medical Center

Address:

MIZTSAMIOULI district

国家:

多哥共和国

省(直辖市):

高原区

市(区县):

Country:

The Republic of Togo

Province:

Region of Plateau

City:

单位(医院):

高原区医院

具体地址:

高原区

Institution
hospital:

Plateau Hospital

Address:

Region of Plateau

经费或物资来源:

中国政府 

Source(s) of funding:

Chinese government 

研究疾病:

疟疾 

Target disease:

Malaria 

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:

上市后药物 

Study phase:

研究目的:

评价青蒿素-哌喹片(ATQ)和蒿甲醚-本芴醇(Coartem)在马拉维、多哥和科摩罗治疗无并发症恶性疟的有效性和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of Artemisinin-piperazine (ATQ) and Artemether-copropenol (Coartem) in the treatment of uncomplicated falciparum malaria in Malawi, Togo and Comoros. 

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:6个月-60岁 2. 显微镜检查无并发症恶性疟; 3. 高疟疾流行区无性体原虫数2000–200 000/μL ,低疟疾流行区无性体原虫数1000–100 000/μL; 4. 腋下温度≥ 37.5 °C或招募前24h有发热史; 5. 具有吞咽口服药物的能力; 6. 有能力和意愿在研究期间遵守协议,并遵守研究随访; 7. 如病人是儿童,需要取得其家长或监护人的知情同意。 

Inclusion criteria

1. Age: 6 months to 60 years old; 2. Uncomplicated falciparum malaria in microscopic examination; 3. The number of asexual protozoa is 2000–200 000/μL in high malaria endemic areas,and is 1000–100 000/μL in low malaria endemic areas; 4. Axillary temperature>= 37.5 degree C or had fevered in 24 hours 5. Having ability to swallow oral medication; 6. Having ability and willingness to abide by the protocol during the study and following the study follow-up; 7. If the patient is a child, should obtain informed consent form from the parent or guardian. 

排除标准:

1. 根据世卫组织(2000)的定义,5岁以下一般危险迹象或重症恶性疟疾患儿; 2. 显微镜检测的混合型疟疾感染者; 3. 根据WHO(2006年)儿童成长标准,严重营养不良患儿; 4. 除疟疾以外引起的发热性疾病(如麻疹、急性下呼吸道感染、严重腹泻导致的脱水)及其它未知的慢性、严重疾病(心、肾、肝疾病,艾滋病); 5. 干扰抗疟药药代的其他常规用药; 6. 对任何正在测试或用作替代治疗的药物有过敏反应或禁忌症史者; 7. 妊娠测试呈阳性或哺乳期妇女; 8. 不能或不愿采取避孕措施的育龄期妇女。 

Exclusion criteria:

1. According to the definition of WHO(2000), children under 5 years old with general signs of danger or symptoms of severe falciparum malaria; 2. Mixed malaria patients in microscopic examination; 3. According to the WHO (2006) Child Growth Standard, severely malnourished children; 4. Fever caused by measles, acute lower respiratory tract infection, severe diarrhea with dehydration, other known chronic or serious diseases (such as heart, kidney or liver disease, AIDS) expect malaria 5. Other routine medications that interfere with pharmacokinetics of antimalarial drug 6. Allergic reactions or contraindications to any drug being tested or used as an alternative treatment of the disease; 7. Pregnancy test positive or lactating women; 8. Women of childbearing age who are unable or unwilling to take contraceptive measures. 

研究实施时间:

Study execute time:

From2019-10-01To 2020-04-30 

干预措施:

Interventions:

组别:

对照组

样本量:

600

Group:

Control group

Sample size:

干预措施:

服用蒿甲醚和本芴醇

干预措施代码:

Intervention:

Taking Coartem

Intervention code:

组别:

试验组

样本量:

600

Group:

Test group

Sample size:

干预措施:

服用青蒿素哌喹片

干预措施代码:

Intervention:

Takeing Artequick

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

马拉维共和国 

省(直辖市):

利隆圭 

市(区县):

 

Country:

Republic of Malawi 

Province:

Lilongwe 

City:

 

单位(医院):

Kamuzu中心医院 

单位级别:

 

Institution
hospital:

Kamuzu Central Hospital  

Level of the institution:

 

国家:

科摩罗联盟 

省(直辖市):

大科摩罗岛 

市(区县):

 

Country:

Union of Comoros 

Province:

Grande Comore 

City:

 

单位(医院):

MBENI区医疗中心 

单位级别:

 

Institution
hospital:

MBENI District Medical Central  

Level of the institution:

 

国家:

科摩罗联盟 

省(直辖市):

大科摩罗岛 

市(区县):

 

Country:

Union of Comoros 

Province:

Grande Comore 

City:

 

单位(医院):

MIZTSAMIOUL区 

单位级别:

 

Institution
hospital:

MIZTSAMIOUL District  

Level of the institution:

 

国家:

多哥共和国 

省(直辖市):

高原区 

市(区县):

 

Country:

The Republic of Togo 

Province:

Region of Plateau 

City:

 

单位(医院):

高原区医院 

单位级别:

 

Institution
hospital:

Plateau Hospital  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

疟原虫密度

指标类型:

主要指标 

Outcome:

Plasmodium Density

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞

指标类型:

主要指标 

Outcome:

leukocyte

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白

指标类型:

主要指标 

Outcome:

Hemoglobin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血细比容

指标类型:

主要指标 

Outcome:

Hematocrit

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血生化

指标类型:

主要指标 

Outcome:

Blood chemistry

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

主要指标 

Outcome:

Electrocardiogram

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿液学检查

指标类型:

主要指标 

Outcome:

Urine examination

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

妊娠试验

指标类型:

主要指标 

Outcome:

Pregnancy test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶性疟原虫体外药敏试验

指标类型:

主要指标 

Outcome:

Susceptibility test of Plasmodium falciparum in vitro

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗疟药物耐药性的分子标记检测

指标类型:

主要指标 

Outcome:

Molecular marker detection for antimalarial drug resistance

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血药浓度

指标类型:

主要指标 

Outcome:

Blood concentration

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:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

Urine

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 0.5 years
最大 Max age 60 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):

专业生物统计学负责人产生随机序列,采用SAS软件或Excel进行三个国家的多中心分层,再在各中心内随机分组。

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

The random sequence will generated by professional biostatisticians using SAS or Excel.

盲法:

单盲 请说明施盲对象。

Blinding:

Single blind.

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

纸质

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

paper

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-09-11
返回列表