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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01490138
Recruitment Status : Unknown
Verified December 2011 by Zhao Weili, Ruijin Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : December 12, 2011
Last Update Posted : December 12, 2011
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

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 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.

Condition or disease
Fungal Infection

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 4-8 weeks. Serum Glucan levels will be measured 2 times per week until the recovery of the infection or treatment end.

Study Type : Observational
Estimated Enrollment : 50 participants
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 Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The patients with compromised immune condition, such as acute leukemia, lymphoma, myeloma, allogeneic stem cell transplantation or long term immune suppression treatment.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01490138

Sponsors and Collaborators
Ruijin Hospital
Merck Sharp & Dohme Corp.
Principal Investigator: Weili ZHAO, PhD Ruijin Hospital

Responsible Party: Zhao Weili, Professor, Ruijin Hospital Identifier: NCT01490138     History of Changes
Other Study ID Numbers: G-test and IFI
First Posted: December 12, 2011    Key Record Dates
Last Update Posted: December 12, 2011
Last Verified: December 2011

Keywords provided by Zhao Weili, Ruijin Hospital:
β-D-Glucan test

Additional relevant MeSH terms:
Communicable Diseases
Invasive Fungal Infections