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CTRI Number  CTRI/2024/03/063801 [Registered on: 07/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Prescribing Pattern of Antibiotic in Admitted Patient in Surgery Department 
Scientific Title of Study   An Observational Study on the Prescribing Pattern of Cephalosporins in Patients Admitted in the Department of General Surgery, SMS Hospital, Jaipur 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akhilesh Meena  
Designation  PG Resident Pharmacology 
Affiliation  SMS Medical College  
Address  Department of Pharmacology SMS Medical College Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  7302908460  
Fax    
Email  akhimeena1109@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chetna Meena 
Designation  Senior Professor 
Affiliation  SMS Medical College  
Address  Department of Pharmacology SMS Medical College Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  9414980943  
Fax    
Email  chetnamahak@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Akhilesh Meena  
Designation  PG Resident Pharmacology 
Affiliation  SMS Medical College  
Address  Department of Pharmacology SMS Medical College Jaipur

Jaipur
RAJASTHAN
302004
India 
Phone  7302908460  
Fax    
Email  akhimeena1109@gmail.com  
 
Source of Monetary or Material Support  
2C/3C Ward General Surgery Department SMS Hospital Jaipur  
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 Akhilesh Meena  SMS Hospital  IPD WARD 2C/ 3C General Surgery SMS Hospital Jaipur
Jaipur
RAJASTHAN 		 7302908460

akhimeena1109@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Office of The Ethics Committee SMS Medical College and Attached Hospital Jaipur   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  79.00 Year(s)
Gender  Both 
Details  All admitted adult patients in the department of General Surgery, who will be prescribed Cephalosporins.
Patients giving consent for participation in study. 
 
ExclusionCriteria 
Details  Patient enrolled in any other study.
Non cooperative patient. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the drug prescribing pattern of Cephalosporins in Inpatient department of General Surgery as per WHO core indicators:
A. Average number of drugs per encounter.
B. Percentage of drugs prescribed by generic name.
C. Percentage of encounters with an antimicrobial prescribed.
D. Percentage of encounters with an injection prescribed.
E. Percentage of drugs prescribed from Essential Drugs List (EDL), Rajasthan. (According to 22nd list, 2022)
To study the use of different generations of Cephalosporins. 		 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To describe the duration of administration of Cephalosporins.
To describe switchover of route of administration, if done.
To assess antimicrobial culture and sensitivity, if done.
To assess the hypersensitivity test, if done.
To assess the use of concomitantly given antimicrobials/ other drugs, for any drug interactions, if any.
To assess the sociodemographic profile correlated with the study patients.
To study and report adverse drug reactions, if any with Cephalosporins. 		 6 Months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/03/2024 
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="6"
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 - NO
Brief Summary  

  • In developing countries, most common cause of morbidity and mortality is infectious diseases. The use of antimicrobials has decreases morbidity and mortality from infectious diseases over the last 50 years worldwide. In the ever-evolving battle against infectious diseases, antibiotics have played a pivotal role in saving countless lives and shaping modern medicine. However, the effectiveness of these life-saving drugs is increasingly threatened by the emergence of antibiotic-resistant bacteria. This ominous challenge has prompted researchers, healthcare professionals, and policymakers worldwide to reevaluate the use of antibiotics and explore new strategies for their judicious and responsible administration.
  • The use of antibiotics, particularly cephalosporins, remains a cornerstone of modern medicine, underpinning the successful management of a wide array of bacterial infections. However, as antibiotic resistance continues to escalate, the judicious and responsible use of these critical drugs becomes paramount. India has largest infectious disease burden in the world. The mortality rate is 417/1 lakh persons from infectious diseases in India. The global burden of infectious diseases is on the rise. as the global healthcare community grapples with the grave consequences of antibiotic resistance. The need for precision in antibiotic use has never been more urgent, and the research presented in this article promises to provide insights that can inform clinical decision-making, optimize patient care, and contribute to the overarching goal of preserving the efficacy of antibiotics for generations to come. 
  • Cephalosporins, a group of antibiotics encompassing multiple generations, have been a vital tool in the hands of healthcare providers for decades. They have played a pivotal role in combating bacterial infections and safeguarding patients’ well-being. However, their effectiveness is increasingly jeopardized by factors such as inappropriate prescribing, suboptimal dosing, and the emergence of antibiotic-resistant strains of bacteria.
  • Cephalosporins are the most commonly used class of antimicrobials. These are bactericidal in mechanism of action which inhibit bacterial cell wall synthesis. They are preferred over other classes of antibiotics because of lower hypersensitivity reactions, broad spectrum of action and better outcomes. Among them third generation Cephalosporins are the most commonly prescribed drug. 
  • First and second-generation Cephalosporin such as cefazolin and cefuroxime are mainly used for surgical prophylaxis whereas third generation cephalosporin generally not recommended. Despite this, third generation Cephalosporin have been widely accepted as the most common antimicrobials for surgical prophylaxis.

 

  • As the global healthcare community grapples with the repercussions of antibiotic resistance—an issue that threatens to erode the efficacy of these vital drugs, various studies have been done to provide valuable insights into the current state of Cephalosporin use, offering a foundation upon which healthcare providers and policymakers can build strategies for improved antibiotic stewardship.

 
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