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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  
N/A 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B376||Candidal endocarditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
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
 
 
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    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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.       .

 
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