| CTRI Number |
CTRI/2026/01/100119 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of fungal infections in ICU patients to assess the incidence of fungal infections |
|
Scientific Title of Study
|
Study of fungal infections in critically ill patients admitted in ICU trhough serological tests An 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 Vishaka Sreeja |
| Designation |
Junior resident |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376441755 |
| Fax |
|
| Email |
sreejareddyvishaka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Bikram Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8400100128 |
| Fax |
|
| Email |
bikramgupta03@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Bikram Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences BHU |
| Address |
Department of Anaesthesiology
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8400100128 |
| Fax |
|
| Email |
bikramgupta03@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh India 221005 |
|
|
Primary Sponsor
|
| Name |
Dr Vishaka Sreeja |
| Address |
Institute of Medical Sciences Banaras Hindu University Varanasi 221005 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prof Bikram Kumar Gupta |
Sir Sunderlal Hospital |
Department of Anaesthesiology Institute of Medical Sciences
Banaras Hindu Universit
Varanasi
UTTAR PRADESH |
8400100128
bikramgupta03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, BHU, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B377||Candidal sepsis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Pts admitted to ICU for more than 48 hours
Patients clinically suspected of having invasive fungal infections.
Informed consent obtained from the patient or legally authorized
representative |
|
| ExclusionCriteria |
| Details |
Patients with only superficial fungal infections.
• Immunocompetent patients with no risk factors for IFIs.
• Patients who decline to provide consent or withdraw from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the incidence and spectrum of fungal infections
in critically ill ICU patients. |
In patients admitted in ICU for more than 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify major risk factors associated with fungal infections in ICU settings. |
15 days after the sample collection |
To isolate & identify fungal species through blood cultures and
serological assays like beta-D-glucan, galactomannan, & mannan. |
15 days after the sample collection |
| To assess outcomes like mortality, ICU stay duration, in patients with fungal infections |
4 weeks after the sample collection |
|
|
Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
12/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We hypothesize that there is an increasing burden of fungal
infections among ICU patients, particularly those with known risk
factors such as neutropenia, immunosuppression, and prolonged ICU
stay. |