- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning
Kontakter och platser
Studieorter
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Beijing, Kina, 100044
- Rekrytering
- Institute of Hematology, the People's Hospital, Peking University
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Kontakt:
- Xiao Jun Huang, professor
- Telefonnummer: 86-10-88324984
- E-post: xjhrm@medmail.com.cn
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Kontakt:
- Yu Ji, postgraduate
- Telefonnummer: 86-10-68792785
- E-post: jiyuhope@163.com
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Huvudutredare:
- Xiao Jun Huang, professor
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
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Utredare
- Huvudutredare: Xiao Jun Huang, Professor, Peking University Institute of Hematology
Studieavstämningsdatum
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Studiestart
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
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Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
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Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HXJ-DFI-001
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