| CTRI Number |
CTRI/2023/11/059380 [Registered on: 01/11/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlating Diagnostic Accuracy of Clinical Features and Biomarkers to detect fungal infections in Intensive Care Unit |
|
Scientific Title of Study
|
Correlating Diagnostic Accuracy of Clinical Features and Biomarkers to detect fungal infections in Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| GMCH/IEC/2023/1042R |
Protocol Number |
| GMCH/IEC/2023/208 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naini Sood |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College and Hospital , Sector 32 , Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
7814052011 |
| Fax |
|
| Email |
nainisood9474@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Jindal |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004171 |
| Fax |
|
| Email |
swatirohitjindal604@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Jindal |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care, Block D, Level 5, GMCH, Sector 32, Chandigarh, India
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646004171 |
| Fax |
|
| Email |
swatirohitjindal604@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE AND HOSPITAL, SECTOR -32, CHANDIGARH |
|
|
Primary Sponsor
|
| Name |
Naini Sood |
| Address |
Department of Anaesthesia and Intensive Care, GMCH- 32, Chandigarh |
| Type of Sponsor |
Other [Naini Sood] |
|
|
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 |
| DrNaini sood |
GMCH- 32 CHANDIGARH |
GOVERNMENT MEDICAL COLLEGE AND HOPSITAL, Sector-32, Chandigarh
Chandigarh
CHANDIGARH |
7814052011
nainisood9474@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R21||Rash and other nonspecific skin eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive patients admitted to the ICU and more than or equal to 18 yrs of age will be eligible for inclusion in the study . The patients may or may not be on mechanical ventilation. |
|
| ExclusionCriteria |
| Details |
1.Patient/family who refused to take part in the study.
2.Patient expires before the seventh day of ICU admission.
3.Patient discharged before sampling ( treatment day <7)
4.Incomplete medical record.
5. Patient on anti fungal therapy before specimen collection preceding ICU admission. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the role of CRP and PCT for predicting fungal infection in patients admitted to Intensive Care Unit. |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the role of other biomarkers like TLC, Platelet Count, IL-6,ESR and fungal cultures in predicting fungal infections in patients admitted to Intensive Care Unit. |
1 year 7 months |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
13/11/2023 |
| 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="6"
Days="26" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nainisood9474@gmail.com].
- For how long will this data be available start date provided 04-11-2023 and end date provided 01-03-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is an Observational study and will be conducted in patients more than or equal to 18 yrs of age admitted to the Intensive Care Unit. They may or may not be on mechanical ventilation.The aim of the study is to correlate clinical features and biomarkers to detect fungal infections in Intensive Care Unit. |