Status:
UNKNOWN
Investigation of Clinical Relevance of β-D-Glucan Tests in Patients With Invasive Fungal Infection (IFI)
Lead Sponsor:
Ruijin Hospital
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Fungal Infection
Eligibility:
All Genders
18+ years
Brief Summary
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 suppre...
Detailed Description
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-...
Eligibility Criteria
Inclusion
- Patients with proven or probable IFI and immunocompromised because of hematopoietic-cell transplantation (HSCT) or chemotherapy, and have positive results for serum Glucan tests will be included in the study.
- Patients must satisfy all the following criteria before entering the study :
- Episode of proven or probable IFI, diagnosed according to the EORTC/MSG definitions;
- Immunocompromised because of HSCT or chemotherapy for malignant hematopathy;
- ≥ 2 consecutive positive serum glucan level, using a threshold for positivity of ≥ 60 ng/L, at the start of antifungal therapy.
Exclusion
- If the fungal infection of the patient is excluded or confirmed to be a specific pathogen other than fungi before the enrollment/during the study period, he or she will be excluded/withdrew from the study.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01490138
Start Date
January 1 2012
End Date
June 1 2014
Last Update
December 12 2011
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