FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/09/045558 [Registered on: 15/09/2022] Trial Registered Prospectively
Last Modified On: 18/10/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding the prevalence of antibiotic resistance and its treatment in hospital-acquired bloodstream infection cases 
Scientific Title of Study   Prevalence and Rationale of Treatment of Carbapenem-Resistant Enterobacteriaceae (CRE) in Hospital Acquired Bloodstream Infection in Adult ICUs 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chiranjay Mukhopadhyay 
Designation  Professor and Associate Dean 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology, 2nd floor, Basic Science building, Madhavnagar, Manipal - 576104, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9845513057  
Fax    
Email  chiranjay.m@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Ms Isha Mathur 
Designation  Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology, 2nd floor, Basic Science building, Madhavnagar, Manipal - 576104, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9910158864  
Fax    
Email  isha.mathur@learner.manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Ms Isha Mathur 
Designation  Student 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Microbiology, 2nd floor, Basic Science building, Madhavnagar, Manipal - 576104, Karnataka

Udupi
KARNATAKA
576104
India 
Phone  9910158864  
Fax    
Email  isha.mathur@learner.manipal.edu  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR), V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Manipal Academy of Higher Education Manipal 
Address  Manipal Academy of Higher Education, manipal.edu building, Madhavnagar, Manipal - 576104, Karnataka 
Type of Sponsor  Research institution and hospital 
 
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 Chiranjay Mukhopadhyay  Kasturba Medical College  Department of Microbiology, 2nd floor, Basic Sciences building, Manipal Academy of Higher Education, Madhavnagar, Manipal - 576104, Karnataka
Udupi
KARNATAKA 
9845513057

chiranjay.m@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba 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: B968||Other specified bacterial agents as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  - Patients admitted to ICU with suspicion of infection or with a blood culture positive report
- Follow up records available 
 
ExclusionCriteria 
Details  - Patients discharged against medical advice and or follow up not available
- Adequate blood samples not available for culture 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Identification of the prevalence of carbapenem resistance in Enterobacteriaceae.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Analysing the patterns of carbapenem resistance in Enterobacteriaceae.  4 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   19/09/2022 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

In the present ‘post-antibiotic era’, understanding the prevalence of Carbapenem-resistant GNBs is of utmost importance since it is the first step toward effective antimicrobial stewardship and prevention and control of infection. Awareness regarding the consequence of CRE infections resulting in high mortality and morbidity and collating the real-world data are critical as these help in making evidence-based decisions that may improve clinical outcomes. Further, this study will help develop an understanding of the socio-economic implications of the increased average length of hospital stay, loss of income and out-of-pocket expenditures. WHO has also identified Carbapenem-resistant GNBs as critical pathogens, and data from continuous monitoring is crucial for urgent drug discovery, research and subsequent development programs. This study will help in understanding the microbiological diagnosis of antibiotic resistance, comprehending clinical-microbiological correlation and treatment planning with a very limited arsenal of antibiotics. From this perspective, the study is planned to understand the microbiological nature of bloodstream infections in the laboratory, with a focus on the phenotypic and genotypic determination of antibiotic resistance and clinical correlation to the treatment outcome. 

 
Close