| CTRI Number |
CTRI/2023/07/055119 [Registered on: 12/07/2023] Trial Registered Prospectively |
| Last Modified On: |
11/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
diagnosis of invasive fungal infections |
|
Scientific Title of Study
|
To evaluate the role of 1,3-Beta-D-Glucan for diagnosing invasive fungal infections in adults in ICU- a prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinesh Chandra Bishnoi |
| Designation |
DNB SS resident doctor |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital
2, Press Enclave Road, Saket, New Delhi 2, Press Enclave Road, Saket, New Delhi,110017 South DELHI 110017 India |
| Phone |
8824175705 |
| Fax |
|
| Email |
doctor.dcb@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Omender Singh |
| Designation |
Principal Director Critical Care Medicine |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital
2, Press Enclave Road, Saket, New Delhi 2, Press Enclave Road, Saket, New Delhi,110017 South DELHI 110017 India |
| Phone |
9205076072 |
| Fax |
|
| Email |
omender.singh@maxhealthcare.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Dinesh Chandra Bishnoi |
| Designation |
DNB SS resident doctor |
| Affiliation |
Max Super Speciality Hospital |
| Address |
Max Super Speciality Hospital
2, Press Enclave Road, Saket, New Delhi 2, Press Enclave Road, Saket, New Delhi,110017 South DELHI 110017 India |
| Phone |
8824175705 |
| Fax |
|
| Email |
doctor.dcb@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital |
| Address |
2, Press Enclave Road, Saket, New Delhi, 110017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Dinesh Chandra Bishnoi |
Max Super Speciality Hospital |
6th floor MICU, west wing, institute of critical care medicine South DELHI |
8824175705
doctor.dcb@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Max Healthcare Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B376||Candidal endocarditis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Candida Score>3 for Invasive Candidiasis OR
2)Fulfilling Meersseman criteria for Invasive Aspergillosis
|
|
| ExclusionCriteria |
| Details |
1)Patients < 18 years
2)Patients already on antifungal treatment
3)Unwillingness to participate in study
|
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of 1,3-beta-D-Glucan assay for the diagnosis of invasive fungal infections in adults admitted in ICU |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To calculate mortality and duration of stay in ICU of IFIs in a tertiary care medical ICU. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="102" Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Invasive fungal infections are becoming more common across the world and are associated with significant death rates, particularly in the immunocompromised population. IFI is related with a number of risk factors, including neutropenia, extended hospitalisation, HIV infection, haematological malignancies, bone marrow transplantation, solid organ transplantation, chemotherapy, and the use of immunosuppressive medications. IFI is becoming more common in non-neutropenic patients in intensive care units. Candida and Aspergillus species cause the majority of IFI in the critical care environment. If not treated early, IFIs are linked to significant morbidity, including death rates of 30–70% owing to aspergillosis and 40–50% due to candidiasis. IFI is difficult to diagnose because clinical symptoms and radiographic findings, as well as traditional microbiological and histological procedures, are less sensitive. Fungal culture normally takes 2 to 4 days to provide findings, on the other hand histological investigation is challenging in most situations. Therefore, a quick and reliable diagnosis of IFI using a simple and convenient technique is needed. BDG is a fungal cell-wall polysaccharide that is released into the bloodstream in people with IFIs. The BDG test has been widely utilised, and the results are incorporated in the European Organization for Research and Treatment of Cancer/Mycoses Study Group (EORTC/MSG) updated IFI diagnostic criteria. Broad-spectrum antibiotics, dialysis, and the usage of immunoglobulins have all been identified as confounding variables for false positive test . Only a few studies from India have been published on role of the BDG test in the diagnosis of IFI. We therefore planned this study to assess the role of BDG test in adult population in ICU with a high risk of IFI. . |