| CTRI Number |
CTRI/2025/09/094009 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
How special antibiotics are used in patients with and without proven infections |
|
Scientific Title of Study
|
Utilization of restricted antibiotics in culture positive and culture negative sepsis 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 |
K Gunasri |
| Designation |
Junior consultant |
| Affiliation |
Apollo hospitals |
| Address |
21 second floor
multi disciplinary critical care unit Apollo hospitals Greams lane
Greams road
Chennai
TAMIL NADU
600006
India |
| Phone |
9444977483 |
| Fax |
|
| Email |
k.gunasri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh Kumar Sundaramurthy |
| Designation |
Consultant |
| Affiliation |
Apollo hospitals |
| Address |
21 second floor
Multi disciplinary critical care unit Apollo hospitals
Greams lane
Greams road
Chennai
TAMIL NADU
600006
India |
| Phone |
9999942084 |
| Fax |
|
| Email |
surkum85@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Gunasri |
| Designation |
Junior consultant |
| Affiliation |
Apollo hospitals |
| Address |
21 second floor
multi disciplinary critical care unit Apollo hospitals
Greams lane
Greams road
TAMIL NADU
600006
India |
| Phone |
9444977483 |
| Fax |
|
| Email |
k.gunasri@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Apollo hospitals |
| Address |
21 Greams lane
Greams road chennai 600006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 K Gunasri |
Apollo hospitals |
Second floor Multi disciplinary critical care unit
Apollo hospitals
21 greams lane
Greams road
Chennai
TAMIL NADU |
9444977483
k.gunasri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee bio medical research Apollo hospitals chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A499||Bacterial infection, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
All patients aged more than 18 years who are receiving restricted antibiotics which includes Carbapenem polymyxin tigecyclin ceftazidime avibactum aztreonem teicoplanin at our multi disciplinary critical care unit. |
|
| ExclusionCriteria |
| Details |
Patients who are not receiving restricted antibiotics.
Patients discharged or deceased within 24 hours of antibiotic initiation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the defined daily dosage of restricted antibiotics administered to culture positive and culture negative sepsis. |
Third day and seventh day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To explore the reasons for non de escalation of restricted antibiotics in both groups
To evaluate the utility of biomarkers such as pro calcitonin in guiding de escalation.
To evaluate the impact of infectious disease specialist on de escalation practices. |
Third day & seventh day |
|
|
Target Sample Size
|
Total Sample Size="251"
Sample Size from India="251"
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)
|
15/09/2025 |
| 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="0"
Months="3"
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
|
To compare the defined daily dosage of restricted antibiotics which includes carbapenem polymyxin tigecyclin ceftazidime avibactum aztreonem teicoplanin in culture positive and culture negative sepsis with primary outcome as mentioned above and secondary outcome of to explore the reasons for non de escalation of restricted antibiotics and to evaluate the role of biomarkers and infectious disease specialist in de escalation of restricted antibiotics in patients getting admitted into our multi disciplinary critical care unit over a period of three months a prospective observational study. |