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An open label, randomized, parallel controlled trial for comparing of the efficacy of anti-fungal treatment for aspergillus infection recurrence after aspergillus globulectomy
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注册号:

Registration number:

ChiCTR1800019990 

最近更新日期:

Date of Last Refreshed on:

2018-12-11 

注册时间:

Date of Registration:

2018-12-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

单中心、前瞻性、非盲、随机、24个月、平行组研究比较曲霉球切除术后抗真菌治疗对曲霉菌感染复发的影响 

Public title:

An open label, randomized, parallel controlled trial for comparing of the efficacy of anti-fungal treatment for aspergillus infection recurrence after aspergillus globulectomy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

单中心、前瞻性、非盲、随机、24个月、平行组研究比较曲霉球切除术后抗真菌治疗对曲霉菌感染复发的影响 

Scientific title:

An open label, randomized, parallel controlled trial for comparing of the efficacy of anti-fungal treatment for aspergillus infection recurrence after aspergillus globulectomy 

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:

梁硕 

研究负责人:

梁硕 

Applicant:

Liang Shuo 

Study leader:

Liang Shuo 

申请注册联系人电话:

Applicant telephone:

+86 18021070508 

研究负责人电话:

Study leader's telephone:

+86 18021070508 

申请注册联系人传真 :

Applicant Fax:

+86 021-55663299 

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:

liangshuo79@163.com 

研究负责人电子邮件:

Study leader's E-mail:

liangshuo79@163.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:

上海市杨浦区政民路507号上海市肺科医院呼吸科 

研究负责人通讯地址:

上海市杨浦区政民路507号2号楼9楼 

Applicant address:

507 Zhengmin Road, Shanghai, China 

Study leader's address:

507 Zhengmin Road, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

200433 

研究负责人邮政编码:

Study leader's postcode:

200433 

申请人所在单位:

上海市肺科医院 

Applicant's institution:

Shanghai Pulmonary Hospital 

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:

K18-209Y 

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:

上海市肺科医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Shanghai Pulmonary Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-05 

伦理委员会联系人:

张雷 

Contact Name of the ethic committee:

Zhang Lei 

伦理委员会联系地址:

上海市杨浦区政民路507号 

Contact Address of the ethic committee:

507 Zhengmin Road, Shanghai, 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:

上海市肺科医院 

Primary sponsor:

Shanghai Pulmonary Hospital 

研究实施负责(组长)单位地址:

上海市杨浦区政民路507号 

Primary sponsor's address:

507 Zhengmin Road, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市肺科医院

具体地址:

政民路507号

Institution
hospital:

Shanghai Pulmonary Hospital

Address:

507 Zhengmin Road, Shanghai, China

经费或物资来源:

上海市肺科医院临床研究项目 

Source(s) of funding:

Clinical Trail Project of Shanghai Pulmonary Hospital 

研究疾病:

真菌性肺病 

Target disease:

Fungal pulmonary disease 

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:

IV期临床试验 

Study phase:

研究目的:

本研究设计为将手术后病理确诊的曲霉球患者作为受试者,进行单中心、随机、平行分组、前瞻性的为期2年的临床研究,评估抗真菌药物对曲霉球患者的复发风险与安全性的差异。通过定期访视记录入组患者曲霉球复发、生活质量、及其它指标等,明确何种方案更适合于这一特定的曲霉球人群,何种治疗方案对改善患者的生活质量、减少曲霉球复发更具优势,最终改善曲霉球患者的预后。研究成果将为制定、修订和优化国际及国内慢性曲霉菌肺病的临床指南与专家共识提供高质量的循证医学证据,有效提升曲霉球患者的临床诊疗效果,形成曲霉球诊疗的最新观念。 

Objectives of Study:

The purpose of this study was to evaluate the difference of recurrence risk and safety of antifungal drugs in aspergilloma patients with pathologically confirmed aspergilloma after surgery by a single-center, randomized, parallel-grouped, prospective two-year clinical study. Through regular visits to record the recurrence of aspergilloma, quality of life, and other indicators of the patients in the study group, it is clear which program is more suitable for this particular aspergilloma population, which treatment program is more advantageous to improve the quality of life of patients, reduce the recurrence of aspergilloma, and ultimately improve the prognosis of patients with aspergilloma. The research results will provide high-quality evidence-based medical evidence for the formulation, revision and optimization of international and domestic clinical guidelines and expert consensus on chronic aspergillosis, effectively enhance the clinical efficacy of aspergillosis, and form the latest concept of aspergillosis diagnosis and treatment. 

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:

须符合以下所有入选条件。 1)曲霉球发生在肺内。 2)病理明确诊断为曲霉球并手术切除患者; 3)签署书面知情同意书。 

Inclusion criteria

All the following qualifications must be met: 1) Aspergillus occurs in the lungs; 2) Pathological diagnosis of aspergilloma and surgical resection; 3) Sign written informed consent. 

排除标准:

1)合并侵袭性肺曲霉病、肺结核等其他肺部疾病的患者; 2)正在妊娠或哺乳或者计划在研究期间妊娠的女性,或有生育能力但未采用有效避孕方法的女性。 

Exclusion criteria:

1) Patients with invasive pulmonary aspergillosis, tuberculosis and other pulmonary diseases; 2) Women who are pregnant or breastfeeding or planning to conceive during the study period, or women who are fertile but do not use effective contraceptive methods. 

研究实施时间:

Study execute time:

From2019-01-01To  

征募观察对象时间:

Recruiting time:

From2019-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

2

样本量:

60

Group:

2

Sample size:

干预措施:

抗真菌治疗

干预措施代码:

Intervention:

anti-fungal treatment

Intervention code:

组别:

1

样本量:

60

Group:

1

Sample size:

干预措施:

不进行抗真菌治疗

干预措施代码:

Intervention:

Without anti-fungal treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市肺科医院 

单位级别:

三甲专科医院 

Institution
hospital:

Shanghai Pulmonary Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

曲霉菌感染复发

指标类型:

主要指标 

Outcome:

Recurrence of Aspergillus infection

Type:

Primary indicator 

测量时间点:

24个月

测量方法:

胸部CT

Measure time point of outcome:

24 months

Measure method:

Chest CT scan

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

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:

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 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):

研究者,简单随机方法

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

Researcher, Simple Random Method

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

2021-12-31

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

2021-12-31

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:

病历记录表

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2018-12-11
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