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CTRI Number  CTRI/2023/05/052245 [Registered on: 02/05/2023] Trial Registered Prospectively
Last Modified On: 28/04/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Survey for detection of superbugs affecting ill patients coming to hospital in emergency. 
Scientific Title of Study   Screening for Multidrug resistant Organism colonization and associated risk factors among the critically ill patients attending Emergency Department: A targeted surveillance strategy for infection prevention 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ujjwala Gaikwad 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Department of Microbiology All India Institute of Medical Sciences Raipur G E Road Tatibandh Raipur Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  8518881724  
Fax    
Email  ujugaikwad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ujjwala Gaikwad 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Department of Microbiology All India Institute of Medical Sciences Raipur G E Road Tatibandh Raipur Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  8518881724  
Fax    
Email  ujugaikwad@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ujjwala Gaikwad 
Designation  Additional Professor 
Affiliation  AIIMS Raipur 
Address  Department of Microbiology All India Institute of Medical Sciences Raipur G E Road Tatibandh Raipur Chhattisgarh

Raipur
CHHATTISGARH
492099
India 
Phone  8518881724  
Fax    
Email  ujugaikwad@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Raipur 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Raipur 
Address  All India Institute of Medical Sciences G E Road Tatibandh Raipur Chhattisgarh 
Type of Sponsor  Government medical college 
 
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 Ujjwala Gaikwad  All India Institute of Medical Sciences Raipur  Emergency ward, ground floor, Trauma and emergency block, AIIMS Raipur, GE Road, Tatibandh, Raipur
Raipur
CHHATTISGARH 
8518881724

ujugaikwad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC AIIMS RAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z229||Carrier of infectious disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NA 
 
Inclusion Criteria  
Age From  14.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Critically ill patients attending emergency department of AIIMS Raipur for any medical or surgical condition.
2. Patients with previous history of hospitalization of at least 48 hours for any reason and referred to AIIMS Raipur for further care.
3. Patients with history of repeated contact with the health care facilities (irrespective of duration of hospitalization) for various procedures like dialysis, wound management, chemotherapy etc.
4. Patients > 14 years of age
 
 
ExclusionCriteria 
Details  1. Patients having diarrhea
2. Patients not willing to participate in the study
3. Patients coming with shorter emergency observations (like URI, UTI, asthma exacerbation etc.) and not admitted in triage area
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Proportion of overall MDRO colonization among new admissions
Proportion of individual MDRO colonization among new admissions
Proportion of individual MDRO colonization among all colonized patients
 
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of individual risk factor with any MDRO colonization   1 year 
 
Target Sample Size   Total Sample Size="521"
Sample Size from India="521" 
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)   01/07/2023 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   No publication out of this trial yet. 
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 - None of the above

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ujugaikwad@gmail.com].

  6. For how long will this data be available start date provided 21-12-2024 and end date provided 21-12-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Infections caused by Multi drug resistant Organisms (MDROs) in hospitalized patients are difficult to treat and hence are associated with high morbidity and mortality. Patients with co-morbidities, long standing hospitalization, use of invasive devices and high consumption of broad-spectrum antimicrobial agents are particularly vulnerable to acquire such infections. Development of infection or invasive disease by MDROs is typically preceded by colonization of the patients with these pathogens.

In a tertiary care health care facility like AIIMS Raipur, where patients are mostly referred from other hospitals after being hospitalised for a long period of time and being exposed to multiple antimicrobial agents, it is expected that patients arriving are already infected/colonized with MDROs. These patients have the potential to spread MDRO to other non-infected patients, health care workers, and the hospital environment. Such patients, if identified early for the presence of MDRO, followed by isolation (contact precautions) from other patients, will help to reduce the spread of these pathogens. However, due to limited resources to conduct this as a regular activity in a long run, universal screening of all patients admitted to an ICU/ward may not always be feasible. On the contrary, resources can be best utilised to gain the most benefit from this activity if they are targeted to a specific group of patients and the most common MDRO causing colonisation.

In light of this, the current study is designed to collect baseline information on the most common MDRO and a group of patients at high risk of colonisation at the time of admission in emergency department of AIIMS Raipur. This type of targeted surveillance can be incorporated into the institute’s routine infection control and prevention activities and can help to control hospital acquired infections caused by emerging MDROs.

 

 
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