| CTRI Number |
CTRI/2026/01/102041 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to find how often infections occur in adult ICU patients and what increases the risk |
|
Scientific Title of Study
|
Incidence and risk factors for Gram negative infections among adult ICU patients -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 |
Shivaani A |
| Designation |
PG Student |
| Affiliation |
Manipal Hospital |
| Address |
Manipal Hospital
Department of Critical care medicine
98,HAL ,Old Airport road
Bengaluru
Manipal Hospitals,
Department of critical care medicine
98,HAL,Old Airport Road
Bengaluru
560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9994771717 |
| Fax |
|
| Email |
shivaharshini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesha Padyana |
| Designation |
Consultant |
| Affiliation |
Manipal Hospital |
| Address |
Manipal Hospital
Department of Critical care medicine
98,HAL ,Old Airport road
Bengaluru
Manipal Hospital
Department of critical care medicine
98,HAL,Old Airport Road
Bengaluru
560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9448843933 |
| Fax |
|
| Email |
padyana@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shivaani A |
| Designation |
PG Student |
| Affiliation |
Manipal Hospital |
| Address |
Manipal Hospital
Department of critical care medicine
98,HAL ,Old Airport road
Bengaluru
Manipal Hospitals,
Department of Critical care medicine
98,HAL,Old Airport Road
Bengaluru
560017
Bangalore
KARNATAKA
560017
India |
| Phone |
9994771717 |
| Fax |
|
| Email |
shivaharshini@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manipal Hospitals,
Department of Critical care medicine,
98,HAL,Old Airport road
Bengaluru,India-560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Hospital |
| Address |
Manipal Hospitals
Department of critical care medicine
98,HAL,Old Airport Road
Bengaluru,India-560017
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Shivaani A |
Manipal Hospital |
Department of critical care medicine
98,HAL,Old Airport Road
Bengaluru,India-560017
Bangalore
KARNATAKA |
9994771717
shivaharshini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients with culture proven gram negative isolates ,presenting with infection |
|
| ExclusionCriteria |
| Details |
Isolated infections caused by organisms other than gram negative group |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the incidence of gram negative infections among adult ICU patients in a tertiary care hospital |
14 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.to identify risk factors associated with gram negative infections in adult ICU patients
2.to determine microbiological spectrum & antibiotic resistance patterns of gram negative organisms
3.To evaluate clinical outcomes (length of ICU stay,duration of mechanical ventilation, need for RRT & mortality ) associated with gram negative infections. |
14 months |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
10/02/2026 |
| 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="2"
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
|
This study aims to determine how common Gram-negative infections are among adults admitted to the Intensive Care Unit (ICU) and to identify the factors that increase the risk of developing these infections. Gram-negative bacteria are a major cause of serious hospital-acquired infections and are often resistant to multiple antibiotics, making treatment difficult for critically ill patients.
The study will be conducted as a prospective observational study in a tertiary care hospital ICU. Adult patients will be followed from the time of ICU admission until discharge or death. Clinical details, comorbidities, severity scores, use of invasive devices, antibiotic exposure, and microbiological results will be recorded. Whenever an infection is suspected, appropriate samples will be collected and processed according to standard guidelines.
The incidence of Gram-negative infections will be calculated, and potential risk factors will be analyzed to determine which variables independently increase the likelihood of infection. The study will also describe the bacterial spectrum, antibiotic resistance patterns, and outcomes such as ICU stay, need for organ support, and mortality. The findings may help improve infection control and guide empirical antibiotic policies in ICUs
|