| CTRI Number |
CTRI/2023/07/055921 [Registered on: 31/07/2023] Trial Registered Prospectively |
| Last Modified On: |
18/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Usefulness of Beta-D Glucan (BDG) test in the treatment of fungal diseases in intensive care setup |
|
Scientific Title of Study
|
Utility of (1–3)-β-D Glucan (BDG) in the management of invasive fungal diseases in critical care unit |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sri Showmiya G |
| Designation |
Academic registrar |
| Affiliation |
Apollo hospital, Off Greams road, chennai |
| Address |
Dept of critical care medicine,2nd floor, main block, Apollo hospital,No:21, Greams lane, off greams road, chennai
Apollo hospital
Chennai
TAMIL NADU
600006
India |
| Phone |
9916215247 |
| Fax |
0 |
| Email |
gsrishowmiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ashwin K Mani |
| Designation |
consultant |
| Affiliation |
Apollo hospital, Off Greams road, chennai |
| Address |
Dept of critical care medicine, 2nd floor, main block, Apollo hospital,No:21, Greams lane, off greams road, chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
6380915692 |
| Fax |
0 |
| Email |
ashwin.mani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sri Showmiya G |
| Designation |
Academic registrar |
| Affiliation |
Apollo hospital, Off Greams road, chennai |
| Address |
Dept of critical care medicine,2nd floor, main block, Apollo hospital,No:21, Greams lane, off greams road, chennai
Chennai
TAMIL NADU
600095
India |
| Phone |
9916215247 |
| Fax |
0 |
| Email |
gsrishowmiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apollo Hospitals,No: 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu– 600006 |
|
|
Primary Sponsor
|
| Name |
Apollo Hospitals |
| Address |
Greams Lane, 21, Greams Rd, Thousand Lights, Chennai, Tamil Nadu 600006 |
| 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 Sri ShowmiyaG |
Apollo main hospital |
Department of Critical care unit, 2nd floor, Main block, No: 21, Greams Lane, Off Greams Road, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU |
9916215247
gsrishowmiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Apollo Institutional Ethics Committee-bio medical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B49||Unspecified mycosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Above 18 years of age who are admitted in critical acre unit for whom BDG test ahs been ordered |
|
| ExclusionCriteria |
| Details |
No specific exclusion criteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the impact of BDG in therapeutic decision making |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To know the indication for ordering BDG assay.   
|
1 year |
| 2. To enumerate the host factors for acquiring IFD.  |
1 year |
|
|
Target Sample Size
|
Total Sample Size="330"
Sample Size from India="330"
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)
|
31/07/2023 |
| 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 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
|
patient admitted in critical care unit above 18 years of age for whom Beta-D-Glucan test has been ordered will be included in the study. following which, data will be collected in two ways, one set demographic details & microbiological laboratory data will be collected by the principal investigator, and the other set data from the physician who is ordering the BDG test. patient followed up until their ICU stay. |