| CTRI Number |
CTRI/2024/07/071439 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
" An observational study to evalaute the oppurtunities to reduce the burden of antibiotic use in critically ill patients" |
|
Scientific Title of Study
|
Evaluating opportunities for antibiotic de-escalation and its clinical impact in
an 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 |
Dr Harsha Vardhini C P |
| Designation |
Assistant Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Critical Care Department,
Medical Icu : First Floor
St Johns Medical College Hospital
Sarjapur Road
Bangalore
St Johns Medical College Hopsital
Sarjapur Road
Bangalore
560034
Bangalore
KARNATAKA
560034
India |
| Phone |
7795986575 |
| Fax |
|
| Email |
HARSHUS2012@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harsha Vardhini C P |
| Designation |
Assitant Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Critical Care Department
Medical Icu- First Floor
St Johns Medical College Hospital
Sarjapur Road
Bangalore
St Johns Medical College Hopsital
Sarjapur Road
Bangalore
560034
Bangalore
KARNATAKA
560034
India |
| Phone |
7795986575 |
| Fax |
|
| Email |
HARSHUS2012@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsha Vardhini C P |
| Designation |
Assitant Professor |
| Affiliation |
St Johns Medical College Hospital |
| Address |
Critical Care Department
Medical Icu-First Floor
St Johns Medical College Hospital
Sarjapur Road
Bangalore
St Johns Medical College Hopsital
Sarjapur Road
Bangalore
560034
Bangalore
KARNATAKA
560034
India |
| Phone |
7795986575 |
| Fax |
|
| Email |
HARSHUS2012@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| St Johns Medical College Hospital
Sarjapur Road
Bangalore : 560034
State : Karnataka
Country : India |
|
|
Primary Sponsor
|
| Name |
St Johns Medical College Hospital |
| Address |
St Johns Medical College Hospital
Sarjapur Road
Bangalore 560034
State : Karnataka
Country: India |
| Type of Sponsor |
Private 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 Harsha Vardhini |
St Johns Medical College Hospital |
Critical Care Department
Medical Icu
St Johns Medical College Hospital
Sarjapur Road
Bangalore : 560034
State: Karnataka
Country : India
Bangalore
KARNATAKA |
7795986575
HARSHUS2012@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ST JOHNS MEDICAL COLLEGE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with suspected infection/sepsis, started on empirical antibiotic therapy for more than or equal to 24 hours.
Patients who will are admitted in ICU for at least 5 days or more. |
|
| ExclusionCriteria |
| Details |
Patients on antibiotics as definitive therapy as per culture sensitivity. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevalence of antibiotic de-escalation. |
during icu stay |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
length of ICU
stay, mortality among the study population, new onset organ failure, emergence of resistance |
discahrge or death |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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)
|
05/08/2024 |
| 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
|
Among critical care patients, apart from the patient factors, there is lack of definition of antimicrobial de-escalation which fits all the clinical scenarios. Additionally, there is no consensus available for hierarchy of antimicrobials 2. In our study the aim is to evaluate the scope available for antimicrobial de-escalation, and to determine the impact of the same in critically ill patients of a tertiary care medical ICU. |