Study 5 of 16 for search of: "Fungemia"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT
This study is currently recruiting participants.
Verified by Peking University, April 2007
Sponsors and Collaborators: Peking University
Merck
Information provided by: Peking University
ClinicalTrials.gov Identifier: NCT00460330
  Purpose

The purpose of this study is to assess the cut-off value of GM/G test in Chinese patients after hematopoietic stem cell transplantation, and evaluate GM/G test and real-time PCR for diagnosis of IFI in Chinese patients.


Condition
Invasive Fungal Infection
Aspergillosis
Fungemia
Hematopoietic Stem Cell Transplantation

MedlinePlus related topics: Fungal Infections Molds
U.S. FDA Resources
Study Type: Observational
Study Design: Screening, Cross-Sectional, Defined Population, Retrospective/Prospective Study
Official Title: The Value of Real-Time Polymerase Chain Reaction (RT-PCR) Assay, Galactomannan and β-D-Glucan Detection (GM/G-Test) for Diagnosis of Invasive Fungal Infection (IFI) in Chinese Patients After Hematopoietic Stem Cell Transplantation (HSCT)

Further study details as provided by Peking University:

Estimated Enrollment: 120
Study Start Date: April 2007
Estimated Study Completion Date: December 2008
Detailed Description:

Invasive fungal infection is one of the major complications of HSCT recipients, and the incidence is increased rapidly in recent years. IFI also commonly occurs in Chinese HSCT recipients, and there is no formal report on the mortality and morbidity of IFI in Chinese patients, so this study could supply these data.

Galactomannan(GM) is a cell wall component of aspergillus only, which is released to the blood stream when the aspergillus grows. While the β-D-glucan(BG) is in the most fungal cell wall, and the high level of BG in body fluid is also an evidence of fungal infection. In this study, the serum level of GM and BG would be detected by the commercial available kit.

We will assess the cut-off value of GM/G test by proven/probable IFI patients and negative controls. Then, we could calculate the sensitivity, specificity, positive and negative predict value of the GM/G test. Meanwhile, we may find out the genus of the fungus by comparison of the two methods. For example, both positive of GM and G-test may suggest that the pathogen is Aspergillus, while the positive G-test and negative GM-test implies the Candida may be the pathogen.

RT-PCR is also a helpful method for the IFI diagnosis, which is more sensitive than GM and G-test and encompassing multiple fungal genera. The small-subunit rRNA gene sequence is relatively conserved among members of fungal kingdom, including the Aspergillus and Candida species, the dimorphic fungi, the agents of zygomycosis, and Pneumocystis. So we will amplify that part of DNA and using gene specific probe to detect whether the sample is positive for fungus or not. Until now, there is no report about real-time PCR assay for diagnosis of IFI in Chinese HSCT recipients, so we want to carry out this study. At the same time, the result of real-time PCR assay could help us to estimate the coincidence of GM and G-test with the IFI patients.

After performing the above three diagnostic test, we could identify the HSCT recipients whether they have the IFI more accurately, so that we could evaluate the antifungal therapy and find out the risk factors for IFI in those patients more accurately.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent fever(>38.0℃) after three days broad-spectrum anti-bacteria or virus therapy
  • Chinese patients after hematopoietic stem cell transplantation

Exclusion Criteria:

  • Severe hemolysis patients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00460330

Contacts
Contact: Xiao Jun Huang, professor 86-10-88324984 xjhrm@medmail.com.cn
Contact: Yu Ji, postgraduate 86-10-68792785 jiyuhope@163.com

Locations
China
Institute of Hematology, the People's Hospital, Peking University Recruiting
Beijing, China, 100044
Contact: Xiao Jun Huang, professor     86-10-88324984     xjhrm@medmail.com.cn    
Contact: Yu Ji, postgraduate     86-10-68792785     jiyuhope@163.com    
Principal Investigator: Xiao Jun Huang, professor            
Sponsors and Collaborators
Peking University
Merck
Investigators
Principal Investigator: Xiao Jun Huang, Professor Peking University Institute of hematology
  More Information

Study ID Numbers: HXJ-DFI-001
Study First Received: April 11, 2007
Last Updated: April 12, 2007
ClinicalTrials.gov Identifier: NCT00460330  
Health Authority: China: Ethics Committee

Keywords provided by Peking University:
diagnosis
galactomannan
glucan
real-time PCR
invasive fungal infection
aspergillosis
Chinese patients

Study placed in the following topic categories:
Systemic Inflammatory Response Syndrome
Mycoses
Sepsis
Fungemia
Aspergillosis
Inflammation

Additional relevant MeSH terms:
Communicable Diseases
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on January 16, 2009