| 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
|
|
|
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
|
|
|
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
|
|
|
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. |