This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Zhao Weili, Ruijin Hospital.
Recruitment status was:  Enrolling by invitation
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital Identifier:
First received: December 8, 2011
Last updated: December 9, 2011
Last verified: December 2011

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.

Fungal Infection

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Zhao Weili, Ruijin Hospital:

Estimated Enrollment: 50
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)
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.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01490138

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

Responsible Party: Zhao Weili, Professor, Ruijin Hospital Identifier: NCT01490138     History of Changes
Other Study ID Numbers: G-test and IFI
Study First Received: December 8, 2011
Last Updated: December 9, 2011

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

Additional relevant MeSH terms:
Communicable Diseases
Mycoses processed this record on July 19, 2017