Clinical Trial of Pulmonary Cryptococcosis in China

Cryptococcosis Clinical Trial

— MCTOPCIC  

Official title:

Multi-center Clinical Trial of Pulmonary Cryptococcosis in China

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02503449
• Other study ID #: LYN-316
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 28, 2014
• Last updated: July 17, 2015
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of the study:1.Improve the understanding of the risk factors of pulmonary cryptococcosis;2.Improve the awareness of pulmonary cryptococcosis clinical and imaging manifestations;3.Grasp pulmonary cryptococcosis patients of clinical and imaging manifestations in different conditions;4.Learn about antibacterial activity of antifungal drugs for cryptococcosis in China.

Description:

1. Patients corresponding to inclusion criteria and obtaining informed consent are included in the research in department of respiration ward in cooperative hospitals.

2. Relevant case report forms are created in this study.

3. Basic information such as age,weight and height is recorded in selected cases.Clinical manifestations,risk factors,laboratory examination,imaging examination,etiological examination and histopathological examination are also recorded in selected cases by case report forms.In addition,antifungal treatment is recorded including name,dose,time of starting treatment and terminate treatment.Causes of terminate treatment and curative effect evaluation should be analysed.

4. Statistical analysis.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 260
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients possess clinical or imaging manifestations of pulmonary infections,with any of the results(by one of following conditions) by microbiological examination or histopathologic examination

1. Cryptococcal capsular polysaccharide antigen of blood or pleural effusion is positive

2. Cryptococcus(fungus culture) is discovered by lower respiratory tract specimens

3. Cryptococcus(pleural effusions culture) is discovered by pleural effusions collected under sterile condition

4. Cryptococcus(pus culture) is discovered by pus smear out of pulmonary infections in disseminated infection patients

5. Cryptococcus(blood culture) is discovered by microscopy of specimens of blood smear

6. Cryptococcus is discovered by culturing of the pathological tissue specimens in aseptic condition

7. Cryptococcal capsular budding yeast with inflammatory reaction is discovered by histopathological examination,cell pathology examination or microscopic examination in aseptic condition

Exclusion Criteria:

1. Patients suffer from acquired immune deficiency syndrome

2. Patients or their legal guardians request to withdraw the clinical research

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cryptococcosis

Locations

Country	Name	City	State
n/a

Sponsors (28)

Lead Sponsor

Collaborator

Zhixin Liang

Beijing Chao Yang Hospital, Chinese PLA General Hospital, First Affiliated Hospital of Zhejiang University, First Hospital of China Medical University, Fujian Provincial Hospital, Fuzhou General Hospital, Fuzhou Pulmonary Hospital of Fujian, Guangzhou Institute of Respiratory Disease, Guizhou Provincial People's Hospital, Huadong Hospital, Longyan First Hospital, Ministry of Health, China, Nanjing PLA General Hospital, Peking University Third Hospital, Second Hospital of Jilin University, Shandong Provincial Hospital, Shanghai Zhongshan Hospital, Shengjing Hospital, Shenyang Military General Hospital, Southwest Hospital, China, The First Affiliated Hospital of Nanchang University, The Second Hospital of Hebei Medical University, Tianjin Medical University General Hospital, Wenzhou Medical University, Wuhan TongJi Hospital, Xi’an Jiaotong University College of Medicine, Xiangya Hospital of Central South University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	differences in clinical manifestations of pulmonary cryptococcosis	Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)	30 days	Yes
Secondary	treatment of pulmonary cryptococcosis	Efficacy as measured by recording dose and time of therapy for antifungal agents	30 days	Yes