| CTRI Number |
CTRI/2025/12/099387 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Choosing the Right Antibiotic Based on Lab Tests to Improve Patient Care |
|
Scientific Title of Study
|
Antibiotic Susceptibility Testing guided Antibiotics Utilization Evaluation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anmoljot Singh |
| Designation |
Pharm D Intern |
| Affiliation |
Indus International Hospital |
| Address |
Department of clinical trial. Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India Department of clinical trial. Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India Rupnagar PUNJAB 140507 India |
| Phone |
7888687475 |
| Fax |
|
| Email |
anmolgill3101@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Parminder Kaur |
| Designation |
Medical Superintendent |
| Affiliation |
Indus International Hospital |
| Address |
Admin Department Chandigarh Indus International hospital Ambala Highway Derabassi SAS
Nagar
Rupnagar
PUNJAB
140507
India Admin Department Chandigarh Indus International hospital Ambala Highway Derabassi SAS
Nagar
Rupnagar
PUNJAB
140507
India Rupnagar PUNJAB 140507 India |
| Phone |
8872735888 |
| Fax |
|
| Email |
msiih@indushospitals.com |
|
Details of Contact Person Public Query
|
| Name |
Avantika Chandra |
| Designation |
Manager Clinical Research Department |
| Affiliation |
Indus International Hospital |
| Address |
Department of clinical trial. Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India Department of clinical trial. Indus International hospital Chandigarh Ambala Highway Derabassi
SAS Nagar
Rupnagar
PUNJAB
140507
India Rupnagar PUNJAB 140507 India |
| Phone |
7991451277 |
| Fax |
|
| Email |
avantikabiotech2017@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Indus International Hospital |
| Address |
Indus International Hospital Ambala Chandigarh Highway Derabassi SAS Nagar Rupnagar Punjab 140507 INDIA |
| 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 |
| Awantika Chandra |
Indus International Hospital |
Indus International Hospital Ambala Chandigarh Highway Derabassi SAS Nagar Rupnagar Punjab 140507 INDIA
Rupnagar PUNJAB |
79914515277
avantikabiotech2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indus International Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 or more than 18 years
Admitted with suspected or confirmed bacterial infection
Received at least one antibiotic prescription and AST testing
|
|
| ExclusionCriteria |
| Details |
Viral or fungal infections without bacterial co-infection
Antibiotic prescribed as prophylactic
Discharged against medical advice
Outpatients, patients with incomplete medical records
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the proportion of antibiotic prescriptions that comply with rational antibiotic use when guided by AST results and antimicrobial stewardship recommendations |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To describe resistance & susceptibility patterns among bacterial pathogens isolated from clinical specimens.
To measure the duration of antibiotic therapy in relation to AST findings.
To evaluate the frequency of antibiotic de-escalation or escalation following receipt of AST results.
To assess adverse events associated with antibiotic therapy. |
At baseline & 5th day |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
29/12/2025 |
| 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="6" Days="0" |
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 - NO
|
|
Brief Summary
|
Antibiotics are a cornerstone of modern clinical practice, playing a critical role in the management of infectious diseases across outpatient, inpatient, and intensive-care settings. Unfortunately, due to their widespread misuse and overuse drive the global surge in antimicrobial resistance (AMR). AMR limits therapeutic options, increases morbidity and mortality, and leads to greater financial strain on healthcare systems. Antibiotic susceptibility testing (AST) serves as a approach to optimize antibiotic decision-making by identifying pathogens and quantifying their susceptibility to various antibiotics, AST bridges the gap between empiric therapy and targeted therapy. Empiric regimens, though essential in acute settings, frequently rely on broad-spectrum agents. These medications are valuable for rapid coverage but may contribute disproportionately to AMR. |