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CTRI Number  CTRI/2024/07/071740 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 06/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Retrospective 
Study Design  Other 
Public Title of Study   Catheter and Non-catheter associated Urinary tract infection and their resistance pattern. 
Scientific Title of Study   Antibiotic Resistance Pattern and Factors Associated Urinary Tract Infection And Non-Catheter Associated Urinary Tract Infection: A Retrospective Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ahammad 
Designation  M-Pharm Student 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte , Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9048290499  
Fax    
Email  chadukalthur786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Roopa BS 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte , Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Roopa BS 
Designation  Assistant Professor 
Affiliation  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Paneer, Deralakatte , Mangaluru-575018

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9047155003  
Fax    
Email  roopa.satyanarayan@nitte.edu.in  
 
Source of Monetary or Material Support  
NGSM Institute of Pharmaceutical Sciences Department Of Pharmacy Practice. Deralakatte, Mangalore, Pin Code 575018  
 
Primary Sponsor  
Name  NGSM Institute of Pharmaceutical Sciences 
Address  Department of Pharmacy Practice Derlakkatte,Mangaluru-575018 
Type of Sponsor  Private hospital/clinic 
 
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 Pratheeksha  Justice K S Hegde Charitable Hospital  Department of General Medicine Justice K S Hegde Charitable Hospital Deralakkate , Mangalaruru
Dakshina Kannada
KARNATAKA 		 9945609818

prattyrai91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NGSM Institute of Pharmaceutical 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 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Both genders who underwent catheterization from Jan-2020 to Dec-2023
2.Confirmed as CAUTI following catheterization for more than 48 hours
3.Participants of all ages.
4.Non-CAUTI patients with positive urine culture
5.Participants with mixed flora, multiple organisms and previous CAUTI . 
 
ExclusionCriteria 
Details  Patients who used antibiotics for UTI within three months before the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The frequency and pattern of antibiotic resistance.  When the patient is confirmed of having UTI after 48 hours of catheterization.  
 
Secondary Outcome  
Outcome  TimePoints 
Risk Factors Associated with CAUTI & Non-CAUTI:
, Site of admission
, Residence type
, Length of stay in ICU.
, Catheter Type
, Duration of catheterization
, Length of hospital stay.
, Immunosuppression conditions
, Antibiotic use in the previous three months
,Comorbidities
 		 When the patient is confirmed of having UTI after 48 hours of catheterization.  
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   12/08/2024 
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="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Urinary tract infections (UTls) make up 12%-50% of infections contracted in hospitals, with the primary cause being the utilization of catheters, leading to what is known as catheter associated urinary tract infections (CAUTls). CAUTI emerges as a prominent hospital acquired infection, resulting in considerable morbidity and increased healthcare expenses due to the rise of multidrug-resistant (MDR) uropathogens that exhibit significant resistance to antimicrobial treatments. To assess the anti-microbial susceptibility pattern in Catheter associated urinary tract infection and Non-catheter associated urinary tract infection. To compare the different factors associated with catheter associated urinary tract infection and Non-catheter associated urinary tract infection .
 

 
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