| CTRI Number |
CTRI/2025/04/084137 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
17/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational Study about Antibiotic Susceptibility in General Intensive Care Unit |
|
Scientific Title of Study
|
The microorganism profile with antibiotic susceptibility in the crtitically ill patients in General Intensive Care Unit: 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 |
Sonia Negi |
| Designation |
Junior Resident |
| Affiliation |
IGMC ,Shimla |
| Address |
Department Of Anaesthesia, Indira Gandhi Medical College, Shimla
Department Of Anaesthesia, Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH
171009
India |
| Phone |
7262057727 |
| Fax |
|
| Email |
sonianegi001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Chaudhary |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesia, Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9459301813 |
| Fax |
|
| Email |
Chaudhary.ushaarvind@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Usha Chaudhary |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College |
| Address |
Department of Anaesthesia, Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9459301813 |
| Fax |
|
| Email |
Chaudhary.ushaarvind@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College ,Shimla, Himachal Pradesh ,India , Pincode -171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College |
| Address |
Indira Gandhi Medical College, Lakkar Bazaar Road, Shimla, Himachal Pradesh, India , Pincode-171001 |
| Type of Sponsor |
Government medical college |
|
|
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 Usha Chaudhary |
Indira Gandhi Medical College, Shimla |
General Intensive Care Unit, Department of Anaesthesia,Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH |
9459301813
Chaudhary.ushaarvind@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, IGMC,Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B998||Other infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adults with endotracheal tube in situ for more than 24 hrs or with tracheostomy tube for 5 to 15 days |
|
| ExclusionCriteria |
| Details |
Patients admitted and intubated for more than 24 hours and then taken in GICU .
Patients on tracheostomy tube for more than 15 days. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the microorganism culture profile in GICU in blood , ETT or tracheostomy tube secretions,urine , blood and cvp tip culture. |
The microorganism culture profile will be assessed in 2-3 days after the collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study antibiotic susceptibility pattern of microorganism isolated. |
One year after approval from ethical committee |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
15/04/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We will be taking culture specimens from different sites for example blood, urine, endotracheal tube secretions or tracheostomy tube secretions,cvp tip .Specimens will be collected from patients who will be admitted in GICU with endotracheal tube in situ within 24 hours of admission or inctubated in GICU itself or with tracheostomy tube in situ for 5 to 15 days.Samples will be sent and processed in department of microbiology in IGMC, Shimla for isolation of microorganisms and their antibiotic susceptibility and resistance will be done .Also correlation will be seen between empirical antibiotics and antibiotic sensitivity in culture report and correlation of microorganism profile between different cultures. |