- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00460330
Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT
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)
Study Overview
Status
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.
Study Type
Enrollment
Contacts and Locations
Study Contact
- Name: Xiao Jun Huang, professor
- Phone Number: 86-10-88324984
- Email: xjhrm@medmail.com.cn
Study Contact Backup
- Name: Yu Ji, postgraduate
- Phone Number: 86-10-68792785
- Email: jiyuhope@163.com
Study Locations
-
-
-
Beijing, China, 100044
- Recruiting
- Institute of Hematology, the People's Hospital, Peking University
-
Contact:
- Xiao Jun Huang, professor
- Phone Number: 86-10-88324984
- Email: xjhrm@medmail.com.cn
-
Contact:
- Yu Ji, postgraduate
- Phone Number: 86-10-68792785
- Email: jiyuhope@163.com
-
Principal Investigator:
- Xiao Jun Huang, professor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Xiao Jun Huang, Professor, Peking University Institute of Hematology
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HXJ-DFI-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fungemia
-
National Institute of Allergy and Infectious Diseases...Completed
-
Hunter Holmes Mcguire Veteran Affairs Medical CenterJohns Hopkins University; Washington University School of Medicine; Weill Medical... and other collaboratorsCompletedMRSA Infection | MRSA Colonization | VRE Infection | VRE Colonization | Nosocomial Bacteremia | Nosocomial FungemiaUnited States
-
Azienda Ospedaliera di PadovaMerck Sharp & Dohme LLCUnknownMycoses | FungemiaItaly
-
Radboud University Medical CenterHorizon 2020 - European CommissionRecruitingCandidemiaNetherlands, United States, Switzerland, Germany, Romania, Greece
-
Instituto do CoracaoFundação de Amparo à Pesquisa do Estado de São PauloCompletedSepsis | Fungemia | BacteremiaBrazil
-
University of PittsburghPfizerCompleted
-
AM-PharmaWithdrawn
-
T2 BiosystemsCompleted
-
Society of Indian Human & Animal MycologistCompleted