Investigation of Clinical Relevance of β-D-Glucan Tests in Patients With Invasive Fungal Infection (IFI)
Invasive fungal infection (IFI) is a disease usually occurred in the patients with compromised immune condition, such as acute leukemia, allogeneic stem cell transplantation or long term immune suppression treatment with the incidence increasing over last decades. Given the introduction of numerous anti-fungal agents and great advance has been made in recent years, IFI is still a dangerous disease with high mortality.
Early diagnosis of IFI is still a problem challenging the physicians. Serum tests of β-D-Glucan are introduced to the diagnosis of IFI, which have the advantage of easy application. However, the value of this test in the monitoring of antifungal treatment remains unclear.
The investigators perform this study to evaluate the correlation of the serum test results of β-D-Glucan test with the treatment response during the anti-fungal treatment, and hope to see that the results of serial serum tests are good predictive markers for treatment response.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Investigation of the Clinical Relevance of Serial Concentrations of β-D-Glucan Tests in the Patients With Invasive Fungal Infection|
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
This is a single center, open-label study. The duration of the study will be 2 years. The number of targeted subjects will be 50 (in 2 years). We estimate that on average, the treatment duration is 4-8 weeks. Serum Glucan levels will be measured 2 times per week until the recovery of the infection or treatment end.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490138
|Principal Investigator:||Weili ZHAO, PhD||Ruijin Hospital|