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CTRI Number  CTRI/2023/01/049058 [Registered on: 17/01/2023] Trial Registered Prospectively
Last Modified On: 03/01/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Proportion of antibiotic resistant organism in infections given initial therapy with higher antibiotics 
Scientific Title of Study   Empirical upfront use of Higher Generation Broad-spectrum Antibiotics: Clinical microbiology correlation-a cross-sectional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amrita Devi M 
Designation  Undergraduate student 
Affiliation  MOSC Medical College 
Address  MOSC Medical College, Kolencherry, Ernakulam
Amritha, Peroor Lane, N.F Gate, tripunithura
Ernakulam
KERALA
682311
India 
Phone  9495444609  
Fax    
Email  amritaa.menon@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Santosh Balakrishnan 
Designation  Associate professor 
Affiliation  MOSC Medical College 
Address  MOSC Medical College

Ernakulam
KERALA
682311
India 
Phone  9747058458  
Fax    
Email  santosurg@gmail.com  
 
Details of Contact Person
Public Query  
Name  Santosh Balakrishnan 
Designation  Associate professor 
Affiliation  MOSC Medical College 
Address  MOSC Medical College


KERALA
682311
India 
Phone  9747058458  
Fax    
Email  santosurg@gmail.com  
 
Source of Monetary or Material Support  
MOSC Medical college 
 
Primary Sponsor  
Name  MOSC Medical College 
Address  MOSC Medical College, Kolencherry, Ernakulam 
Type of Sponsor  Research institution 
 
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 
Amrita Devi M  MOSC Medical College   General medicine,general surgery,Nephrology,Urology, Pulmonology,ICU and critical care areas
Ernakulam
KERALA 		 9495444609

amritaa.menon@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MOSC Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: R652||Severe sepsis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  a)Patients above 18 yrs of age
b)Patients administered Higher generation broad-spectrum antibiotics empirically
c)Culture specimen was taken before starting primary therapy 
 
ExclusionCriteria 
Details  a)Improper documentation of details
b)Patients given higher-generation broad-spectrum antibiotics(HGBSA) without index culture specimens taken. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the proportion of patients started on higher generation broad-spectrum antibiotics who have MDR (multidrug-resistant) organisms in index microbiology culture.  Every 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to determine the clinical parameters associated with MDR microbial infections.  1 year 
 
Target Sample Size   Total Sample Size="777"
Sample Size from India="777" 
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)   01/03/2023 
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   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

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

  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 (Others) -  data wwill be accessible after publication in medical journal or medical conferences

  6. For how long will this data be available start date provided 25-01-2024 and end date provided 01-10-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Patients who present to all clinical departments in a tertiary level teaching hospital in South India are considered. Patients who are administered upfront empirical higher generation broad spectrum antibiotics ( vancomycin, linezolid, meropenem, tigecycline, colistin, piperacillin-tazobactam, cefoperazone-sulbactam), who satisy the inclusion criteria are enrolled after taking informed consent. 
The data is collected based on a purpose designed proforma. The data collected will be entered into an Excel spreadsheet.
The data collected includes patient demographics, clinical diagnosis, culture and laboratory parameters, and the therapy started 
 
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