Clinical Trial of Pulmonary Cryptococcosis in China

Multi-center Clinical Trial of Pulmonary Cryptococcosis in China

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02503449

Acronym

MCTOPCIC

Enrollment

260

Registered

2015-07-21

Start date

2014-12-31

Completion date

2017-12-31

Last updated

2015-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cryptococcosis

Keywords

Pulmonary Cryptococcosis

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
differences in clinical manifestations of pulmonary cryptococcosis	30 days	Methods including laboratory examination(routine blood test),imaging examination(chest CT),scoring system(APACHE II score)

Secondary

Measure	Time frame	Description
treatment of pulmonary cryptococcosis	30 days	Efficacy as measured by recording dose and time of therapy for antifungal agents

Outcome results