FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/074243 [Registered on: 24/09/2024] Trial Registered Prospectively
Last Modified On: 04/10/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   To understand antibiotic prescription in patients at end-stage of illness 
Scientific Title of Study   To understand the antimicrobial prescription patterns in patients with terminal or life-limiting illness in intensive care unit- An 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  Sonali Vadi 
Designation  Consultant  
Affiliation  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute 
Address  First floor, Department of ICU, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (west), Mumbai
Mumbai
Mumbai
MAHARASHTRA
400053
India 
Phone  9090909090  
Fax    
Email  sonali.vadi@kokilabenhospitals.com  
 
Details of Contact Person
Scientific Query
 
Name  Sonali Vadi 
Designation  Consultant  
Affiliation  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute 
Address  First floor, Department of ICU, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (west), Mumbai
Mumbai

MAHARASHTRA
400053
India 
Phone  9090909090  
Fax    
Email  sonali.vadi@kokilabenhospitals.com  
 
Details of Contact Person
Public Query
 
Name  Sonali Vadi 
Designation  Consultant  
Affiliation  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute 
Address  First floor, Department of ICU, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (west), Mumbai
Mumbai

MAHARASHTRA
400053
India 
Phone  9090909090  
Fax    
Email  sonali.vadi@kokilabenhospitals.com  
 
Source of Monetary or Material Support  
Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Andheri (West), Mumbai- 400053, India 
 
Primary Sponsor  
Name  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  
Address  First floor, Department of ICU, Andheri (west), Mumbai 400053, Maharashtra, India  
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonali Vadi  Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute  First floor, Department of ICU, Andheri (west), Mumbai
Mumbai
MAHARASHTRA 
9090909090

sonali.vadi@kokilabenhospitals.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Academics (IEC-A)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R688||Other general symptoms and signs,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Adult ICU
2. Age more than 18 years
3. All genders
4. Patients with terminal or life-limiting illness
 
 
ExclusionCriteria 
Details  Age less than 18 years 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To understand the antimicrobial prescription patterns in patients with terminal or life-limiting illness in intensive care unit  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
none   1 year 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   03/10/2024 
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)
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    

The general goal of antimicrobial therapy is to increase patient’s survival and cure infectious diseases. Because antimicrobial agents are unable to alter the progression of underlying diseases or rather sometimes can prolong suffering in patients at the end-of-life, the goal of prolonging life should be weighed against the risk of prolonging suffering.  Thus, the goal of antimicrobial therapy shifts from improving survival to symptom control with a shift in the goal of care from cure to palliation.  The goal of antimicrobial therapy for terminal patients at an early stage can include symptom control and improvement in survival while maintaining the quality of life.  Antimicrobials however do not change the natural course of disease.  Also, no difference in frequencies of documented symptoms with the use of antimicrobials was seen in a retrospective study at end-of-life. 

We do not have information from the Indian subcontinent.  Results of this audit should serve as a living document for re-visiting antimicrobial prescription practices by physician prescribers and set up antimicrobial stewardship guidelines for terminally ill patients such that these can be viewed as aggressive care in end-of-life situations. 

 

 
Close