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Investigation of Clinical Relevance of β-D-Glucan Tests in Patients With Invasive Fungal Infection (IFI)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01490138
First received: December 8, 2011
Last updated: December 9, 2011
Last verified: December 2011

December 8, 2011
December 9, 2011
January 2012
December 2013   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01490138 on ClinicalTrials.gov Archive Site
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Investigation of Clinical Relevance of β-D-Glucan Tests in Patients With Invasive Fungal Infection (IFI)
Investigation of the Clinical Relevance of Serial Concentrations of β-D-Glucan Tests in the Patients With Invasive Fungal Infection

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

The patients with compromised immune condition, such as acute leukemia, lymphoma, myeloma, allogeneic stem cell transplantation or long term immune suppression treatment.

Fungal Infection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
June 2014
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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 :

  1. Episode of proven or probable IFI, diagnosed according to the EORTC/MSG definitions;
  2. Immunocompromised because of HSCT or chemotherapy for malignant hematopathy;
  3. ≥ 2 consecutive positive serum glucan level, using a threshold for positivity of ≥ 60 ng/L, at the start of antifungal therapy.

Exclusion Criteria:

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01490138
G-test and IFI
Yes
Zhao Weili, Ruijin Hospital
Ruijin Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Weili ZHAO, PhD Ruijin Hospital
Ruijin Hospital
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP