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CTRI Number  CTRI/2026/01/100500 [Registered on: 07/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Severe Antibiotic-Resistant Blood Infections in ICU Patients: Who Is at Risk and What Are the Outcomes? 
Scientific Title of Study   Risk factors and outcomes of patients with metallo-beta-lactamase-producing gram-negative bloodstream bacterial infections in ICU: a prospective observational study. 
Trial Acronym  MBL risk factors 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Prasoon Gupta 
Designation  Consultant 
Affiliation   
Address  Institute of Critical care Medicine, Fourth Floor, D-Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi - 110060
Institute of Critical care Medicine, Fourth Floor, D-Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi - 110060
New Delhi
DELHI
110060
India 
Phone  9891571699  
Fax    
Email  drprasoon.gupta85@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Prasoon Gupta  
Designation  Consultant 
Affiliation   
Address  Institute of Critical care Medicine, Fourth Floor, D-Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi - 110060
Institute of Critical care Medicine, Fourth Floor, D-Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi - 110060
New Delhi
DELHI
110060
India 
Phone  9891571699  
Fax    
Email  drprasoon.gupta85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Prasoon Gupta 
Designation  Consultant 
Affiliation   
Address  Institute of Critical care Medicine, Fourth Floor, D-Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi - 110060
Institute of Critical care Medicine, Fourth Floor, D-Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi - 110060
New Delhi
DELHI
110060
India 
Phone  9891571699  
Fax    
Email  drprasoon.gupta85@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Sir Gangaram Hospital 
Address  Institute of Critical care Medicine, Fourth Floor, D-Block, Sir Gangaram Hospital, Rajinder Nagar, New Delhi - 110060  
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 Pragya Shukla  INSTITUTE OF CRITICAL CARE MEDICINE  Institute of Critical care Medicine, Fourth Floor, D-Block,
Central
DELHI 		 07599296498

pragyashuklakgmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE,SIR GANGA RAM HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B961||Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere,  
 
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  Adult patients in intensive care unit found to have gram negative bacteria (GNB) positive blood stream infection 
 
ExclusionCriteria 
Details  1) Patients already enrolled in any therapeutic intervention study.
2) Patients who have a lab-confirmed bloodstream MBL infection at the time of admission to the ICU.
3) Refusal to participate in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Risk factors of patients having blood stream infection with Metallobetalactamases producing study pathogens.  patients risk factors will be assessed as soon as patients blood is being withdrawn for blood cultures .  
 
Secondary Outcome  
Outcome  TimePoints 
- 28 days all-cause mortality, ICU Length of stay & incidence of blood stream infection with MBL GNB study bacteria.   
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   31/01/2026 
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="8"
Days="14" 
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  

Phenotypic detection of MBLs (e.g., combined disk tests with EDTA) is routinely available in many labs but it is not a molecular diagnostic method. Molecular assays (PCR for common bla genes) like BCID 2 (BioFire Blood Culture Identification 2) provide faster, gene specific identification and are now widely used in clinical settings.   

Our prospective observational study will enrol 600 patients with BCID 2 confirmed carbapenemase producing blood stream infection after obtaining informed consent. Current antibiotic use and its duration will not affect enrolment decision. The study will be limited to gram negative bacterial infections by Acinetobacter baumanii complex, Pseudomonas aeruginosa, and Enterobacterales (Klebsiella spp. & E. coli only).

 

All carbapenemase producing study bacteria will be grouped in to MBL producers and MBL non producers.  Predefined risk factors in both the groups will be studied along with 28-day all-cause mortality and ICU length of stay (ICU LOS). Incidence of MBL GNB in BCID 2 samples will also be calculated.

 

This study might help to find the current incidence of blood stream gram-negative infections with MBL’s, associated patient risk factors and mortality in the setting of a tertiary care ICU. This will help to frame empiric antibiotic policy in the ICU patients in the presence of studied risk factors.

 

 
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