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CTRI Number  CTRI/2023/06/054356 [Registered on: 23/06/2023] Trial Registered Prospectively
Last Modified On: 10/02/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Retrospective, Non interventional 
Study Design  Other 
Public Title of Study   Effectiveness of newer antibiotic combination named as ceftazidime avibactam for the treatment of blood infection due to Multi Drug Resistant gram negative bacteria. 
Scientific Title of Study   Effectiveness of ceftazidime avibactam for the treatment of bacteremia due to MDR gram negative Infection 
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 Deepak Govil 
Designation  Vice Chairman, Critical Care 
Affiliation  Medanta The Medicity, Gurgaon 
Address  Medanta the Medicity Sector 38 Gurgaon Haryana India

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 
Affiliation  Medanta The Medicity, Gurgaon 
Address  Medanta the Medicity Sector 38 Gurgaon Haryana India

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 
Affiliation  Medanta The Medicity, Gurgaon 
Address  Medanta the Medicity Sector 38 Gurgaon Haryana India

Gurgaon
HARYANA
122001
India 
Phone  9818056688  
Fax    
Email  drdeepak_govil@yahoo.co.in  
 
Source of Monetary or Material Support  
Pfizer Limited, The Capital, G Block BKC, Bandra Kurla Complex, Bandra East, Mumbai, Maharashtra 400 102  
 
Primary Sponsor  
Name  Medanta Institute of Education and Research 
Address  Sector38 Gurgaon Medanta the Medicity 10th floor A wing POCU MIER 
Type of Sponsor  Research institution 
 
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 Deepak Govil  Medanta, The Medicity  Sector 38, Gurgaon Haryana, India-122001
Gurgaon
HARYANA 		 9818056688

drdeepak_govil@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Medanta Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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. This study is a single center retrospective, non interventional study.  NIL. This study is a single center retrospective, non interventional study. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients, Bacteremic patients with Documented MDR GNB infection, Received ceftazidimeavibactam for atleast 48 hours as per clinician’s discretion  
 
ExclusionCriteria 
Details  Documented Acinetobacter infection, Pure MBL isolated (if available)  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1) Clinical outcomes at Day 3 & day 14/EOT from the initiation of ceftazidime avibactam 2) Mortality at day 14   Day 3 & Day 14/ End of Treatment 
 
Secondary Outcome  
Outcome  TimePoints 
1) All cause mortality at day 30 2) Day of ceftazidime avibactam initiation, average dose and duration 3) No of patients-initiated with Ceftazidime avibactam within 48-72 hour after diagnosis and outcomes correlation 4) Source of bacteremia 5) Causative organism, median time from admission to isolation of organism from culture 6) Molecular typing outcomes if available, susceptibility for ceftazidime-avibactam 7) Concomitant medications (baseline & combination) 8) Length of hospital stay   Day 30 
 
Target Sample Size   Total Sample Size="125"
Sample Size from India="125" 
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)   30/06/2023 
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)  Closed to Recruitment of Participants 
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   Bacteremia is associated with increased mortality and morbidity. Early initiation of appropriate antibiotics is associated with improved outcomes. Currently there are few options for treating bacteremia due to MDR gram negative infections, one of which is Ceftazidime -avibactam. Real world evidence studies globally have shown its effectiveness in the management of MDR gram negative infections. The epidemiology of MDR gram negative infections in India differs from the epidemiology worldwide and hence demonstrating the effectiveness of ceftazidime avibactam in the Indian scenario is essential. 
The present study will look at the trends in usage of ceftazidime-avibactam (including day of initiation) in bacteremia along with clinical and microbiological outcomes. This study is Single centre, retrospective, non-interventional.  The sample size of the study is 125. Adult patients, Bacteremic patients with Documented MDR GNB infection, Received ceftazidime avibactam for atleast 48 hours as per clinician’s discretion will be included in the study. The patients with documented Acinetobacter infection, Pure MBL isolated will not be included in the study. Primary outcome of the study is 1) Clinical outcomes at Day 3 and day 14/EOT from the initiation of ceftazidime avibactam  2) Mortality at day 14  and Secondary outcome is 1) All cause mortality at day 30  2) Day of ceftazidime avibactam initiation, average dose and duration 3) No of patients-initiated with  Ceftazidime avibactam within  48-72 hour after diagnosis  and outcomes correlation  4) Source of bacteremia 5) Causative organism, median time from admission to isolation of organism from culture 6) Molecular typing outcomes if available, susceptibility for ceftazidime-avibactam 7) Concomitant medications (baseline & combination) 8) Length of hospital stay. The enrollment period for collection of data retrospectively is from Jan 2020 to July 2022. The study duration is of one year.
 
 
 
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