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CTRI Number  CTRI/2019/12/022454 [Registered on: 20/12/2019] Trial Registered Prospectively
Last Modified On: 17/12/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A study in patients with Catheter associated Blood Stream Infections, to study the drug resistance(capacity of disease causing micro-organisms to withstand exposure to drugs) and drug sensitivity patterns. 
Scientific Title of Study   A clinical study of patients with Central Venous Catheter associated Blood Stream Infections (CVC-BSI)-Bacteriological profile, Antimicrobial Resistance Pattern and Clinical course and Outcome. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abisha Rezia R 
Designation  Junior Resident of Pharmacology 
Affiliation  Kempegowda Institute of Medical Sciences, Bangalore 560070 
Address  Department of Pharmacology Kempegowda Institute of Medical Sciences, Banashankari 2nd stage Bangalore 560070
Department of Pharmacology Kempegowda Institute of Medical Sciences, Banashankari 2nd stage Bangalore 560070
Bangalore
KARNATAKA
560070
India 
Phone  09486533058  
Fax    
Email  abisharezia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vijendra R 
Designation  Associate Professor in Dept of Pharmacology 
Affiliation  Kempegowda Institute of Medical Sciences, Bangalore 560070 
Address  Kempegowda Institute of Medical Sciences, Banashankari 2nd stage Bangalore–560 070
Kempegowda Institute of Medical Sciences, Banashankari 2nd stage Bangalore–560 070
Bangalore
KARNATAKA
560070
India 
Phone  09980033334  
Fax    
Email  vijendra_ramaiah@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Vijendra R 
Designation  Associate Professor in Dept of Pharmacology 
Affiliation  Kempegowda Institute of Medical Sciences, Bangalore 560070 
Address  Kempegowda Institute of Medical Sciences, Banashankari 2nd stage Bangalore–560 070
Kempegowda Institute of Medical Sciences, Banashankari 2nd stage Bangalore–560 070
Bangalore
KARNATAKA
560070
India 
Phone  09980033334  
Fax    
Email  vijendra_ramaiah@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Department of Microbiology Kempegowda Institute of Medical Sciences Bangalore  
Address  Kempegowda Institute of Medical Sciences, KR road, Bangalore 560004 
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 R Abisha Rezia  Kempegowda Institute of Medical Sciences Hospital and Research Centre, V V Puram, Bangalore 560004   ICUs of KIMS hospital and research centre , V V Puram, Bangalore 560004
Bangalore
KARNATAKA 
9486533058

abisharezia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kempegowda Institute of Medical Sciences - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A419||Sepsis, unspecified organism,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Subjects with Central Venous Catheters (CVCs) in situ for >3 days of insertion and sterile blood culture immediately after catheterization.
2. Subjects whose CVP tip samples when processed showed significant growth of one or more organisms.
 
 
ExclusionCriteria 
Details  1. Subjects who got central venous catheter (CVC) inserted outside our hospital. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To study the organisms causing CVC-BSI
 
6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the antimicrobial susceptibility pattern among CVC-BSI isolates
2. To study the clinical course and outcome of patients with CVC-BSI
 
6 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   23/12/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Central venous access not only plays an important role in the management of critically ill patients and but also puts the patients at risk of iatrogenic complications. Central Venous Catheters (CVCs) are indispensible in current medical and intensive care treatment and are commonly associated with hospital acquired bloodstream infections. It increases the risk of Catheter Related Infection (CRI) resulting in increased morbidity and mortality. The rate of CVC-BSI across Indian hospitals range from 4.01/1000 catheter days to 9.26/1000 catheter days denoting the need for effective infection control programmes including surveillance and antibiotic policies. Gram-positive cocci - Staph aureus, Staph epidermidis, Staph saprophyticus and MRSA are responsible for at least two-thirds of the infections followed by Gram-negative bacilli - Klebsiella pneumonia, E. Coli, Pseudomonas aeruginosa, Enterococcus spp and Acinetobacter spp. The preventive strategies to reduce the rate of CVC-BSI include the use of antimicrobial impregnated catheters and also aseptic catheter insertion techniques. Due to the scarcity of CVC-BSI data from our region, this study will be taken up in our ICU of the tertiary care hospital to determine the microbiological profile and antimicrobial susceptibility of the CVC-BSI isolates.

 
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