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CTRI Number  CTRI/2024/06/069303 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 19/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Antimicrobial Utilization In Hospital 
Scientific Title of Study   Antimicrobial Utilization In A Intensive Care Unit Of A Tertiary Care Hospital-PG Dissertation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishnan prem 
Designation  Post Graduate 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563101
India 
Phone  9447790835  
Fax    
Email  krishnansuryaster@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sarala N 
Designation  Professor and Head 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka,Kolar

Kolar
KARNATAKA
563101
India 
Phone  9845750165  
Fax    
Email  saralan@sduaher.ac.in  
 
Details of Contact Person
Public Query
 
Name  Sarala N 
Designation  Professor and Head 
Affiliation  Sri Devaraj Urs Medical College 
Address  Department Of Pharmacology, Sri Devaraj Urs Medical College, Tamaka, Kolar

Kolar
KARNATAKA
563101
India 
Phone  9845750165  
Fax    
Email  saralan@sduaher.ac.in  
 
Source of Monetary or Material Support  
Sri Devaraj Urs Medical College,Tamaka,Kolar,Karnataka,India,Pin 563101 
 
Primary Sponsor  
Name  krishnan Prem 
Address  Post Graduate,Department Of Pharmacology,Sri Devaraj Urs Medical College, Tamaka, Kolar,Karnataka,Pin 563101 
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 
DrKrishnan Prem  R L Jalappa Hospital and Research Centre, Sri Devaraj Urs Medical College  Intensive Care Unit, Ground Floor,Department Of Anaethesia,Sri Devaraj Urs Medical College,Tamaka,Kolar India Pin: 563101
Kolar
KARNATAKA 
9447790835

krishnansuryaster@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central ethics committee,Sri Devaraj Urs Academy of Higher Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, (2) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, (3) ICD-10 Condition: G01||Meningitis in bacterial diseases classified elsewhere, (4) ICD-10 Condition: T07||Unspecified multiple injuries, (5) ICD-10 Condition: T36-T50||Poisoning by, adverse effect of and underdosing of drugs, medicaments and biological substances, (6) ICD-10 Condition: J17||Pneumonia in diseases classified elsewhere, (7) ICD-10 Condition: J440||Chronic obstructive pulmonary disease with acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1)Patients of either gender
2)Patients aged between 18-80 years admitted to ICU receiving antimicrobial agents and/or drugs for peptic ulcer
3)Patient who are in ICU for 1-5 days
 
 
ExclusionCriteria 
Details  1)Patients on dialysis
2)Patients on ventilator
3)Patients who stayed less than 24 hours
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
It will show the utilization pattern of antimicrobials in intensive care unit and shows the relationship between Prescribed Daily Dose and WHO defined Daily Dose.   6 months,9 months,12 months,
15 months. 
 
Secondary Outcome  
Outcome  TimePoints 
It wil show the drugs used in peptic ulcer & will reveal the cost of antimicrobial therapy in intensive care unit  6 months,9 months,12 months,
15 months. 
 
Target Sample Size   Total Sample Size="634"
Sample Size from India="634" 
Final Enrollment numbers achieved (Total)= "650"
Final Enrollment numbers achieved (India)="650" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/07/2024 
Date of Study Completion (India) 30/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

Globally there is inappropriate use of antimicrobial agents (AMA) resulting in rise of antimicrobials resistance and this has become an important issue particularly in patients in intensive care units (ICUs). A study has  shown  that physicians commonly prescribe antimicrobials for longer durations than indicated by guidelines. In this they identified many factors that influence prescribing patterns like severity of the illness, the patient’s comorbidities, and the physician’s level of experience. Rapid and correct diagnosis will minimize the use of  empiric broad-spectrum antimicrobials  there by providing  focused antimicrobial therapy. Over time, the necessity of newer antimicrobials has been increasing , more so in the ICU because of the clinical condition the patients present to the physician.

                                             Our study will determine the utilization pattern of antimicrobials based on WHO prescribing indicators in Intensive care unit, also the relationship between Prescribed Daily Dose and WHO Defined Daily Dose and we will also assess the drugs used in peptic ulcers because most of the patients in Intensive care unit will be receiving them. It will also assess the cost of antimicrobial therapy in Intensive care unit.

                              


 
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