Fungal InfectionNCT01490138
Investigation of Clinical Relevance of β-D-Glucan Tests in Patients With Invasive Fungal Infection (IFI)
An observational study of Fungal Infection, run by Ruijin Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fungal Infection
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients with compromised immune condition, such as acute leukemia, lymphoma, myeloma, allogeneic stem cell transplantation or long term immune suppression treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fungal Infection
- Keywords
- β-D-Glucan test, IFI
- Medical subject headings
- Mycoses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili ZHAO, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490138
- Sponsor's protocol ID
- G-test and IFI
- Status last verified
- Dec 2011
- First submitted
- 8 Dec 2011
- Last updated
- 12 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Clinical Relevance of Serial Concentrations of β-D-Glucan Tests in the Patients With Invasive Fungal Infection
- ClinicalTrials.gov ID
- NCT01490138
- Acronym / sponsor ID
- G-test and IFI
- Conditions
- Fungal Infection
- Keywords
- β-D-Glucan test, IFI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 12 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with compromised immune condition, such as acute leukemia, lymphoma, myeloma, allogeneic stem cell transplantation or long term immune suppression treatment.
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weili ZHAO, PhD principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Infection, run by Ruijin Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2011.