FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/02/062846 [Registered on: 19/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To assess the effectiveness of different antibiotics in lung and blood infections caused by carbapenem resistant bacteria  
Scientific Title of Study   A retrOspective, multi-centre study to evalUate the effecTiveness of different antibiotics/ Combinations being used in patients with bloOd stream infection and/ or hospital acquired pneuMonia caused by CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA.  
Trial Acronym  OUTCOME 
Secondary IDs if Any  
Secondary ID  Identifier 
OUTCOME STUDY, Version 2.0, Dated 3rd January 2024  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Deepak Govil 
Designation  Vice Chairman - Critical Care Medicine 
Affiliation  Medanta The Medicity, Gurgaon,  
Address  ICU 9, 10, and 11 Medanta the medicity Sector 38 Gurgaon Haryana 122001

Gurgaon
HARYANA
122001
India 
Phone  9818056688  
Fax    
Email  drdeepak_govil@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepak Govil 
Designation  Vice Chairman - Critical Care Medicine 
Affiliation  Medanta, The Medicity, Gurgaon 
Address  ICU 9, 10, and 11 Medanta the medicity Sector 38 Gurgaon Haryana 122001

Gurgaon
HARYANA
122001
India 
Phone  9818056688  
Fax    
Email  drdeepak_govil@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepak Govil 
Designation  Vice Chairman - Critical Care Medicine 
Affiliation  Medanta, The Medicity, Gurgaon 
Address  ICU 9, 10, and 11 Medanta the medicity Sector 38 Gurgaon Haryana 122001

Gurgaon
HARYANA
122001
India 
Phone  9818056688  
Fax    
Email  drdeepak_govil@yahoo.co.in  
 
Source of Monetary or Material Support  
Medanta the medicity sector 38 Gurgaon Haryana  
 
Primary Sponsor  
Name  Dr Deepak Govil 
Address  Medanta the medicity Sector 38 Gurgaon Haryana 122001 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Neeraj Kumar  All India Institute of Medical Sciences Patna  Phulwarisharif Patna Bihar 801507 India
Patna
BIHAR 		 8210104972

drneerajk@aiimspatna.org 
Dr Anand Gupta  Asian Institute of Gastroenterology   6 3 661 Somajiguda Hyderabad 500082
Hyderabad
TELANGANA 		 9313392757

drandygrmc@gmail.com 
Dr Sarita Kumari  Banaras Hindu University Institute of Medical Sciences  Banaras Hindu University Institute of Medical Sciences Varanasi 221005
Varanasi
UTTAR PRADESH 		 7217647725

drsarita.anesthesia@gmail.com 
Dr Neeraj Tulara  Dr L H Hiranandani Hospital  Hillside Avenue Hiranandani Garden Powai Mumbai 400076
Mumbai
MAHARASHTRA 		 9833552955

drntulara@rediffmail.com 
Dr Vaibhav Bhargava  Fortis Escorts Hospital  Jawhar Lal Nehru Marg Malviya Nagar Jaipur 302017
Jaipur
RAJASTHAN 		 9928787788

drvaibhav79@gmail.com 
Dr Akshay H M  JSS Medical College  Sri Shivarathreeshwara Nagara, Mysuru 570 015 Karnataka
Mysore
KARNATAKA 		 988622812

hmmakshay@gmail.com 
Dr Subhash Todi  Manipal Hospitals East India Private Limited  P 4 and 5 CIT Scheme LXXII Block A Gariahat Road Dhakuria Kolkata 700029
Kolkata
WEST BENGAL 		 9831202040

drsubhashtodi@gmail.com 
Dr Y P Singh  Max Super Speciality Hospital  108 A Indraprastha Ext Patparganj Delhi 110092
East
DELHI 		 8800531155

ypsinghmrt@gmail.com 
Dr Vivek Nangia  Max Super Speciality Hospital Saket  Max Super Speciality Hospital West Block Saket 1 Press Enclave Road Saket New Delhi 110017
New Delhi
DELHI 		 9810048885

Vivek.Nangia@maxhealthcare.com 
Dr Smita Jain  Medanta Hospital, Indore  Plot No. 8, PU4, Scheme no. 54, Vijay Nagar Square, A B Road, Indore, 452010, India
Indore
MADHYA PRADESH 		 9425900760

Smita.Jain@medanta.org 
Dr Deepak Govil  Medanta the medicity  Medanta the medicity Sector 38 Gurgaon Haryana 122001
Gurgaon
HARYANA 		 9818056688

drdeepak_govil@yahoo.co.in 
Dr Ritu Chopra  O.P JINDAL INSTITUTE OF CANCER AND CARDIAC AND RESEARCH  O.P JINDAL INSTITUTE OF CANCER AND CARDIAC AND RESEARCH MODEL TOWN HISAR HARYANA 125005
Hisar
HARYANA 		 9896539130

rituchopra3@yahoo.com 
Dr Kapil Zirpe  Ruby Hall Clinic   40 Sassoon Road Pune 411001
Pune
MAHARASHTRA 		 9822844212

kapilzirpe@gmail.com 
Dr Sanjith Saseedharan  S L Raheja Hospital  Raheja Rugnalaya Marg Mahim West Mahim Mumbai Maharashtra 400016
Mumbai
MAHARASHTRA 		 9004479549

docsanjith@rediffmail.com 
Dr Subhal Dixit  Sanjeevan Hospital  Plot No 23 Off Karve Road Erandwane Pune Maharashtra 411011
Pune
MAHARASHTRA 		 9822050240

subhaldixit@yahoo.com 
Dr Atul Kulkarni  Tata Memorial Hospital  Department of Anaesthesia Critical Care and Pain Tata Memorial Hospital Dr E Borges Road Parel Mumbai 400012
Mumbai
MAHARASHTRA 		 9869077526

kaivalyaak@yahoo.co.in 
Dr Madhusudan R Jaju  Yashoda Academy of Medical Education and Research  Yashoda Hospital Behind Harihara Kala Bhavan Secunderabad 500003
Hyderabad
TELANGANA 		 8668459383

madhu_jaju123@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
Institutional Ethics Committee Biomedical and Health Research PMRF  Approved 
Institutional Ethics Committee Institute of Medical Sciences Banaras Hindu University  Approved 
Institutional Ethics Committee Yashoda Academy of Medical Education and Research  Approved 
Institutional Ethics Committee AIIMS Patna  Approved 
Institutional Ethics Committee AMRI HOSPITALS  Approved 
Institutional Ethics Committee Asian Institute of Gastroenterology IEC AIG  Approved 
Institutional Ethics Committee Balaji Medical & Diagnostic Research Center  Approved 
Institutional Ethics Committee Dr. L H Hiranandani Hospital  Approved 
Institutional Ethics Committee Fortis Hospital, Jaipur  Approved 
Institutional Ethics Committee J.S.S Medical College  Approved 
Institutional Ethics Committee OPJICACRE HISAR  Approved 
Institutional Review Board S L Raheja Hospital  Approved 
Integrity Ethics Committee Care CHL Hospitals  Approved 
Jivanrekha Institutional Ethics Committee  Approved 
Max Healthcare Ethics Committee  Approved 
Medanta Institutional Ethics Committee  Approved 
Tata Memorial Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A415||Sepsis due to other Gram-negativeorganisms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Adult more than 18 years of age with confirmed culture based diagnosis of hospital acquired pneumonia (HAP) (pneumonia developing at least 48 hours after hospital admission) and / or blood stream infection caused by CRE (Klebsiella pneumoniae, Escherichia coli) CRAB & CRPA

Received antibiotic mono and or combination therapy for at-least 48 hours as per clinician’s discretion 
 
ExclusionCriteria 
Details  Culture positive from any site other than blood stream/ pneumonia.
Any organism other than CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA isolated within 14 days of initiation/ EOT of antibiotic therapy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Clinical outcomes of patient with BSI
2. Clinical outcomes of patient with HAP
3. Clinical outcomes of patient with HAP plus BSI
4. Microbiological outcome in patients with BSI
5. Microbiological outcome in patients with HAP
6. Microbiological outcome in patients with HAP plus BSI 		 Day 7 and day 14 or EOT from the initiation of antibiotic mono-/ combination therapy
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Duration of invasive mechanical ventilation (hours)
2. Duration of vasopressor requirement (hours)
3. Need for RRT (Yes/No)
4. Length of hospital stay
5. Length of ICU stay
6. ICU outcome
7. Hospital outcome
 		 7 days and 14 days or end of treatment 
 
Target Sample Size   Total Sample Size="3000"
Sample Size from India="3000" 
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)   29/02/2024 
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  

This is a retrospective, multi-centre study to evaluate the effectiveness of different antibiotics/ combinations being used in patients with blood stream infection and/ or hospital acquired pneumonia caused by CRE (carbapenem resistant enterobacterales-Klebsiella pneumoniae, Escherichia coli), CRAB (Carbapenem resistant Acinetobacter baumanii) & CRPA (carbapenem resistant Pseudomonas aeruginosa). Inclusion criteria for the study includes, adults (≥18 years of age inclusive) with confirmed culture based diagnosis of hospital acquired pneumonia (HAP) (pneumonia developing at least 48 hours after hospital admission) and or blood stream infection caused by CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA, and those who have received antibiotic mono-/ combination therapy for at-least 48hours as per clinician’s discretion. Exclusion criteria includes, culture positive from any site other than blood stream/ pneumonia; any organism other than CRE (Klebsiella pneumoniae, Escherichia coli), CRAB & CRPA isolated within 14 days of initiation/ EOT of antibiotic therapy. Primary outcomes of the study are ‘clinical outcomes of patient with BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy’; ‘clinical outcomes of patient with HAP at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy’; clinical outcomes of patient with HAP plus BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy’; ‘microbiological outcome in patients with BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy, (if available)’; ‘microbiological outcome in patients with HAP at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy, (if available)’; ‘microbiological outcome in patients with HAP plus BSI at Day 7 and day 14/EOT from the initiation of antibiotic mono-/ combination therapy, (if available)’. Secondary outcomes of the study are duration of invasive mechanical ventilation, duration of vasopressor requirement, need for renal replacement therapy, length of hospital stay, length of ICU stay, ICU outcome, and hospital outcome.

 
Close