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CTRI Number  CTRI/2020/07/026868 [Registered on: 29/07/2020] Trial Registered Prospectively
Last Modified On: 20/07/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pilot trial to compare 24 hour antibiotic regimen with standard 7 day antibiotic regimen for prophylaxis in renal transplant recipients. 
Scientific Title of Study   To compare 24 hour versus standard 7 day prophylactic antibiotic regimen in renal transplant recipients: A pilot prospective randomised control study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prasanna Ramana A 
Designation  Junior Resident 
Affiliation  AIIMS 
Address  Surgery Unit 2, department of Surgical Disciplines, All India Institute Of Medical Sciences , New Delhi New Delhi Delhi 110029 India

New Delhi
DELHI
110029
India 
Phone  9742712903  
Fax    
Email  prasannaramana326@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Aggarwal 
Designation  Professor  
Affiliation  All India Institute Of Medical Sciences New Delhi 
Address  Department of Surgical Discipline All India Institute of Medical Sciences New Delhi. New Delhi Delhi 110029 India

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  sandeep_aiims@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Aggarwal 
Designation  Professor 
Affiliation  All India Institute Of Medical Sciences New Delhi 
Address  Department of Surgical Discipline All India Institute of Medical Sciences New Delhi. New Delhi Delhi 110029 India

New Delhi
DELHI
110029
India 
Phone    
Fax    
Email  sandeep_aiims@yahoo.co.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Ansari Nagar , New Delhi, India - 110029. 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences New Delhi 
Address  All India Institute Of Medical Sciences New Delhi 110029 India 
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 
Prasanna Ramana A  All India Institute Of Medical Sciences   Department of Surgical Disciplines
New Delhi
DELHI 		 9742712903

prasannaramana326@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECPG   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N185||Chronic kidney disease, stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  24 hour antibiotic prophylaxis regimen   Injection cefotaxime 1 gram given just before start of surgery , 2nd dose given 8 hours later and the third and final dose after the next 8 hours. 
Comparator Agent  standard 7 day prophylactic regimen  Injection cefotaxime 1 gram given just before start of surgery , 2nd dose given 8 hours later followed by od dose for next 7 days and stopped after removal of the foleys catheter on post operative day 7. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. All Renal transplant recipients except those with cadaveric renal grafts.
2. Patient is able to follow instructions
3. Patients are ready for regular follow up
4. Able to provide informed written consent
 
 
ExclusionCriteria 
Details  1. Cadaveric renal grafts.
2. Non-compliance with medical care or follow up.
3. Patient suffering from psychiatry problems.
4. Unable to give consent or patient refusal.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of SSI in the postoperative period in kidney transplant patients as defined by CDC that is 30 day follow up period in both the groups, UTI, chest infections, central venous catheter related infection.  1 week, 2 weeks and 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Duration of hospital stay, side effects, graft kidney function.  1 week, 2 weeks and 4 weeks. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   14/09/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Antibiotic over use and misuse has led to widespread resistance to antibiotics. The study is aimed at comparing 24 hour prophylactic antibiotic against standard 7 day antibiotic prophylaxis in renal transplant recipients. The recipients will be allocated in to the two groups by permuted block randomisation.  Incidence of SSI in the postoperative period in kidney transplant patients as defined by CDC that is 30 day follow up period in both the groups, UTI, chest infections, central venous catheter related infection will be studied and compared. This will help us to gather preliminary data to establish a relevant antibiotic protocol in renal transplant recipients.



 
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