Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by Peking University.
Recruitment status was  Recruiting
Merck Sharp & Dohme Corp.
Information provided by:
Peking University
ClinicalTrials.gov Identifier:
First received: April 11, 2007
Last updated: April 12, 2007
Last verified: April 2007
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.

Invasive Fungal Infection
Hematopoietic Stem Cell Transplantation

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
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)

Resource links provided by NLM:

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.


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00460330

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

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 Sharp & Dohme Corp.
Principal Investigator: Xiao Jun Huang, Professor Peking University Institute of hematology
  More Information

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

Keywords provided by Peking University:
real-time PCR
invasive fungal infection
Chinese patients

Additional relevant MeSH terms:
Communicable Diseases
Skin Diseases
Skin Diseases, Infectious

ClinicalTrials.gov processed this record on May 02, 2016