| CTRI Number |
CTRI/2025/12/099396 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Infection and sepsis caused by catheter in hospitalized patients, study about new cases and management of the infection. |
|
Scientific Title of Study
|
Catheter induced infection and sepsis in hospitalized patients: An observational study on risk, incidence and clinical outcomes. |
| 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 Divya Dadwal |
| Designation |
Pharm D Intern |
| Affiliation |
Indus International Hospital |
| Address |
Department of clinical trials Indus International Hospital Ambala-Chandigarh Highway Derabassi SAS Nagar Rupnagar Punjab 140507 INDIA
Department of clinical trials Indus International Hospital Ambala-Chandigarh Highway Derabassi SAS Nagar Rupnagar Punjab 140507 INDIA
Rupnagar
PUNJAB
140507
India |
| Phone |
9015000960 |
| Fax |
|
| Email |
dadwaldivya56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parminder Kaur |
| Designation |
Medical Superintendent |
| Affiliation |
Indus International Hospital |
| Address |
Admin Department Indus International Hospital Ambala-Chandigarh Highway Derabassi SAS Nagar Rupnagar Punjab 140507 INDIA
Admin Department Indus International Hospital Ambala-Chandigarh 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 trials Indus International Hospital Ambala-Chandigarh Highway Derabassi SAS Nagar Rupnagar Punjab 140507 INDIA
Department of clinical trials Indus International Hospital Ambala-Chandigarh 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 |
| Dr Divya Dadwal |
Indus International Hospital |
Department of clinical trial
Indus International Hospital
Chandigarh Ambala Highway
Derabassi
SAS Nagar
Punjab
140507
Rupnagar
PUNJAB |
9015000960
dadwaldivya56@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
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients with age above 18 years
Catheterized for 48 or more than 48 hours
|
|
| ExclusionCriteria |
| Details |
Patients with active infections at the time of hospital admission
Immunocompromised patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Identification of high-risk
catheter types/units Trends in antibiotic resistance
|
2 days post catheterization (enrollment day)
5 days post catheterization (discharge day)
10 days post catheterization (follow up visit)
30 days post catheterization |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recommendations for preventive practice |
2 days post catheterization (enrollment day)
5 days post catheterization (discharge day)
10 days post catheterization (follow up visit)
30 days post catheterization |
|
|
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
|
Catheter-associated
infections are a significant contributor to hospital-acquired infections (HAIs), particularly in critically ill and long-term hospitalized patients.
Indwelling catheters—whether urinary, peripheral venous, or central venous—are
essential for patient management but can also serve as conduits for microbial
colonization, biofilm formation, and subsequent systemic infection. If not
identified early, localized infections can progress to sepsis and septic shock,
both of which are associated with increased morbidity, prolonged
hospitalization, and higher mortality. |