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CTRI Number  CTRI/2022/10/046153 [Registered on: 04/10/2022] Trial Registered Prospectively
Last Modified On: 03/10/2022
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Study of bacterial correlation in patients and ICU environment at AIIMS Rishikesh 
Scientific Title of Study   A Comparative study of drug resistance in bacterial isolates from environmental sources and patients with special reference to Critical Care Unit at AIIMS Rishikesh 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankit Agarwal 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesia and Critical Care AIIMS Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone    
Fax    
Email  ankit.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Ankit Agarwal 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesia and Critical Care AIIMS Rishikesh


UTTARANCHAL
249203
India 
Phone    
Fax    
Email  ankit.anaes@aiimsrishikesh.edu.in  
 
Details of Contact Person
Public Query
 
Name  Ankit Agarwal 
Designation  Additional Professor 
Affiliation  AIIMS Rishikesh 
Address  Department of Anesthesia and Critical Care AIIMS Rishikesh


UTTARANCHAL
249203
India 
Phone    
Fax    
Email  ankit.anaes@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
Uttarakhand State Council for Science and Technology 
 
Primary Sponsor  
Name  Uttarakhand State Council for Science and Technology UCOST 
Address  Vigyan Dham Jhajra Dehradun Uttarakhand Pin 248007 
Type of Sponsor  Government funding agency 
 
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 
Ankit Agarwal  Critical Care Unit AIIMS Rishikesh  Department of Anesthesia and Critical Care AIIMS Rishikesh
Dehradun
UTTARANCHAL 
8475000280

ankit.anaes@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All ICU patients with microbiological evidence of infection after 48 hours of admission to ICU

All staff working in the ICU 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Drug resistant bacteria isolated  48 hours of ICU admission minimum 
 
Secondary Outcome  
Outcome  TimePoints 
Antibiotic sensitivity pattern  Within 72 hours of microbial growth 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   15/10/2022 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Publication

  6. For how long will this data be available start date provided 30-09-2024 and end date provided 31-08-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
An ICU has the most seriously ill patients of the hospital. Often the patients are infected with various bacteria. The routine culture sensitivity reporting requires a minimum time interval of 48-72 hours. The patients are so critical that it is not possible to wait for the microbial culture reports and empirical therapy has to be started as early as possible. The microbial population of ICUs is usually different from other areas of the hospital and usually much more resistant as compared to other areas of the hospital. Also many opportunistic pathogens may be present in an ICU Setting. They may be present on equipment being used, other patients, medical and paramedical staff attending them and the surrounding environment of the ICU. Patients in ICU are more susceptible to infections caused by opportunistic pathogens as they have low body resistance due to various underlying diseases, duration of stay in ICU, use of invasive devices like ventilator or catheters etc., immune
suppression or disrupted physiological barriers. These opportunistic bacteria are often resistant to most of the antibiotics due to extreme selective pressure in ICU, making them a highly dangerous source of infection for susceptible patients. Since the susceptibility pattern of bacteria differ from place to place and since the prevalence of predominant microorganisms also varies, the pathogens prevalent in a particular setting along with their susceptibility patterns must be known in order to formulate rationale prescribing of antimicrobials. 
Primary Objective – Since drug resistant opportunistic pathogen are present in the environment of the ICU as well as they are carried by the medical and paramedical staff, an attempt will be made to isolate them from the environment and hands of the medical staff and also from infected patients whose cultures are routinely sent and will be maintained as stock culture to see if a correlation exists between the two. 
Secondary Objective – Their drug susceptibility pattern will also be studied to find out suitable antibiotic to be started empirically before the culture and sensitivity report is available.
 
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