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CTRI Number  CTRI/2020/03/024213 [Registered on: 24/03/2020] Trial Registered Prospectively
Last Modified On: 18/05/2020
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Drug Utilisation Evaluation of antibiotics in Multidrug resistant Urinary Tract Infection. 
Scientific Title of Study   Drug Utilisation Evaluation of antibiotics and the prevalence of multidrug resistant Urinary Tract Infection in a tertiary care hospital in South India. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asthaa Malhotra 
Designation  PharmD intern 
Affiliation  Manipal College of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9740216590  
Fax    
Email  asthaarmalhotra@gmail.con  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kanav Khera 
Designation  Assistant Professor  
Affiliation  Manipal College of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  7889271828  
Fax    
Email  Kanav.khera@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Asthaa Malhotra 
Designation  PharmD intern 
Affiliation  Manipal College of Pharmaceutical Sciences  
Address  Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9740216590  
Fax    
Email  asthaarmalhotra@gmail.con  
 
Source of Monetary or Material Support  
Kasturba Hospital, Manipal, Karnataka, 576104 
 
Primary Sponsor  
Name  Asthaa Malhotra 
Address  Department of Pharmacy Practice, Room no. #1, Kasturba Hospital, Manipal, 576104 
Type of Sponsor  Other [Self] 
 
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 
Asthaa Mahotra  Kasturba Hospital  Department of Pharmacy Practice, Kasturba Hospital, Manipal, Karnataka, 576104
Udupi
KARNATAKA 
9740216590

asthaarmalhotra@gmail.com 
 
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: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients with final diagnosis of UTI resistant to three or more than three classes of antibiotics. 
 
ExclusionCriteria 
Details  Patients file with incomplete data 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Drug Utilisation Evaluation of multi drug resistant Urinary Tract Infection.  10 days 
 
Secondary Outcome  
Outcome  TimePoints 
Most common resistant bacteria
Most common resistant drug 
1 week 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   25/03/2020 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Urinary tract infections are the second most common infections that drive the use of antibiotics, an estimate of 150 million UTIs occur every year globally, this has led to increasing use of empirical therapy and bacterial resistance which in turn cascades into increased treatment failures. Various studies show clear increase in antibiotic resistance among uropathogens. Recurrent urinary tract infections (UTI) are common among young healthy women even though they generally have anatomically and physiologically normal urinary tracts. Hence, the surveillance of antibiotic susceptibility pattern is essential for the appropriate treatment and reduced remission of infection. There is a lack of literature on the prevalence of MDR UTI in South India therefore, this study is carried out to depict the treatment pattern and prevalence of MDR UTI in a 2000 bedded hospital in Karnataka to improve the quality of treatment of patients.
 
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