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CTRI Number  CTRI/2019/12/022486 [Registered on: 23/12/2019] Trial Registered Prospectively
Last Modified On: 18/12/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Antimicrobials used against uropathogens causing Urinary Tract Infection (UTI) and also to study the drug resistance(capacity of disease causing micro-organisms to withstand exposure to drugs) and sensitivity patterns. 
Scientific Title of Study   A clinical study of UTI caused by Multi-Drug Resistant (MDR) uropathogens in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Abisha Rezia R 
Designation  Post Graduate student in MD Pharmacology 
Affiliation  Post Graduate student in MD Pharmacology,Kempegowda Institute of Medical Sciences, Bangalore 
Address  KIMS Ladies hostel Banashankari 2nd stage Bangalore 560070
KIMS Ladies hostel 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  KIMS, Bangalore 
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  Associate professor in Dept of Pharmacology,KIMS, Bangalore 
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  
This study is being conducted in Department of Microbiology, Kempegowda Institute of Medical Sciences, Bangalore 560004. Infrastructural support is being provided by the same. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [Self funded] 
 
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   Department of Microbiology,KIMSH, 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: N390||Urinary tract infection, site notspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Day(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1. Subjects whose urine sample when processed showed significant growth of one or more organisms.  
 
ExclusionCriteria 
Details  1. Subjects whose urine sample was contaminated.
2. Subjects whose urine sample showed no growth.
3. Subjects whose urine sample showed insignificant bacteriuria.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. MDR Uropathogens causing UTI
 		 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Antimicrobial susceptibility pattern
2. Clinical course and outcome  		 6 months 
 
Target Sample Size   Total Sample Size="1500"
Sample Size from India="1500" 
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  

Urinary Tract Infection (UTI) is a common bacterial infection, which contributes to a frequent cause of morbidity in out-patients as well as in hospitalized patients. There are numerous cases of antimicrobial resistance to the commonly used antibiotics in the developed and developing countries. Resistance to newer and more potent antimicrobials are no exceptions, thereby making the therapeutic options very limited to certain antimicrobial agents like carbapenem, colistin and fosfomycin. The updated knowledge and situation of the prevailing bacterial uropathogens that are multidrug resistant (MDR) is of prime importance for the proper use of antimicrobial drugs and also for policy making to combat multidrug resistance in UTIs. Antimicrobial resistance surveillance is necessary to determine the size of the problem and to guide the empirical selection of antimicrobial agents for treating infected patients. This study is aimed to study the profile of MDR uropathogens causing UTI in a tertiary care hospital and assess their antimicrobial susceptibility pattern, clinical course and outcome.

 
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