CryptococcosisMCTOPCICNCT02503449
Clinical Trial of Pulmonary Cryptococcosis in China
An observational study of Cryptococcosis, run by Zhixin Liang.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cryptococcosis
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to Dec 2017
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
- Cryptococcal capsular polysaccharide antigen of blood or pleural effusion is positive
- Cryptococcus（fungus culture) is discovered by lower respiratory tract specimens
- Cryptococcus（pleural effusions culture) is discovered by pleural effusions collected under sterile condition
- Cryptococcus（pus culture) is discovered by pus smear out of pulmonary infections in disseminated infection patients
- Cryptococcus（blood culture) is discovered by microscopy of specimens of blood smear
- Cryptococcus is discovered by culturing of the pathological tissue specimens in aseptic condition
- Cryptococcal capsular budding yeast with inflammatory reaction is discovered by histopathological examination,cell pathology examination or microscopic examination in aseptic condition
Who cannot join
- Patients suffer from acquired immune deficiency syndrome
- Patients or their legal guardians request to withdraw the clinical research
About this study
Official title: Multi-center Clinical Trial of Pulmonary Cryptococcosis in China
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.
Read the detailed description
- Patients corresponding to inclusion criteria and obtaining informed consent are included in the research in department of respiration ward in cooperative hospitals.
- Relevant case report forms are created in this study.
- 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.
- Statistical analysis.
- Conditions
- Cryptococcosis
- Keywords
- Pulmonary Cryptococcosis
- Medical subject headings
- Cryptococcosis
What is being measured
The primary outcome is the main question the study is designed to answer.
differences in clinical manifestations of pulmonary cryptococcosis
Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)
Measured: 30 days
Secondary outcomes (1)
treatment of pulmonary cryptococcosis
Efficacy as measured by recording dose and time of therapy for antifungal agents
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CryptococcosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Zhixin Liang
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Chao Yang Hospital, Ministry of Health, China, Peking University Third Hospital, Tianjin Medical University General Hospital, First Hospital of China Medical University, Shengjing Hospital, Second Hospital of Jilin University, Shandong Provincial Hospital, Huadong Hospital, Nanjing PLA General Hospital, Fuzhou General Hospital, Guangzhou Institute of Respiratory Disease, Wuhan TongJi Hospital, Xi'an Jiaotong University, Guizhou Provincial People's Hospital, General Hospital of Shenyang Military Region, The Second Hospital of Hebei Medical University, Xiangya Hospital of Central South University, Fujian Provincial Hospital, Fuzhou Pulmonary Hospital of Fujian, Southwest Hospital, China, First Affiliated Hospital of Zhejiang University, Wenzhou Medical University, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Nanchang University, Longyan City First Hospital
- Responsible party
- Sponsor-investigator, Zhixin Liang, Chinese PLA General Hospital
- Investigators
- Zhixin Liang, Doctor, Study director, Chinese PLA General HospitalZhen Wang, Principal investigator, Beijing Chao Yang HospitalYanming Li, Principal investigator, Ministry of Health, ChinaLina Sun, Principal investigator, Peking University Third HospitalJie Cao, Principal investigator, Tianjin Medical University General HospitalYunzhuo Chu, Principal investigator, First Hospital of China Medical UniversityZhijie Zhang, Principal investigator, Shengjing HospitalYufen Jin, Principal investigator, Second Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503449
- Sponsor's protocol ID
- LYN-316
- Acronym
- MCTOPCIC
- Status last verified
- Jul 2015
- First submitted
- 28 Dec 2014
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Trial of Pulmonary Cryptococcosis in China
- ClinicalTrials.gov ID
- NCT02503449
- Acronym / sponsor ID
- MCTOPCIC / LYN-316
- Conditions
- Cryptococcosis
- Keywords
- Pulmonary Cryptococcosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Zhixin LiangUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Beijing Chao Yang Hospital, Ministry of Health, China, Peking University Third Hospital, Tianjin Medical University General Hospital, First Hospital of China Medical University, Shengjing Hospital, Second Hospital of Jilin University, Shandong Provincial Hospital, Huadong Hospital, Nanjing PLA General Hospital, Fuzhou General Hospital, Guangzhou Institute of Respiratory Disease, Wuhan TongJi Hospital, Xi'an Jiaotong University, Guizhou Provincial People's Hospital, General Hospital of Shenyang Military Region, The Second Hospital of Hebei Medical University, Xiangya Hospital of Central South University, Fujian Provincial Hospital, Fuzhou Pulmonary Hospital of Fujian, Southwest Hospital, China, First Affiliated Hospital of Zhejiang University, Wenzhou Medical University, Shanghai Zhongshan Hospital, The First Affiliated Hospital of Nanchang University, Longyan City First Hospital
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Patients corresponding to inclusion criteria and obtaining informed consent are included in the research in department of respiration ward in cooperative hospitals.
- Relevant case report forms are created in this study.
- 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.
- Statistical analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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
- Cryptococcal capsular polysaccharide antigen of blood or pleural effusion is positive
- Cryptococcus（fungus culture) is discovered by lower respiratory tract specimens
- Cryptococcus（pleural effusions culture) is discovered by pleural effusions collected under sterile condition
- Cryptococcus（pus culture) is discovered by pus smear out of pulmonary infections in disseminated infection patients
Key exclusion criteria (2 listed)
- Patients suffer from acquired immune deficiency syndrome
- Patients or their legal guardians request to withdraw the clinical research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
differences in clinical manifestations of pulmonary cryptococcosis
Time frame: 30 days
Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)
1 secondary outcome
treatment of pulmonary cryptococcosis
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhixin Liang, Doctor study director
Chinese PLA General Hospital
Zhen Wang principal investigator
Beijing Chao Yang Hospital
Yanming Li principal investigator
Ministry of Health, China
Questions about this trial
What is this clinical trial studying?
An observational study of Cryptococcosis, run by Zhixin Liang.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
differences in clinical manifestations of pulmonary cryptococcosis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2015.