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CTRI Number  CTRI/2023/02/049473 [Registered on: 06/02/2023] Trial Registered Prospectively
Last Modified On: 01/02/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   This is a study to optimise the dosing regimen for Vancomycin so that patient response to the drug can be improved. 
Scientific Title of Study   Comparison of efficacy, safety, pharmacokinetic and pharmacodynamic parameters between conventional dosing regimen of vancomycin with novel optimized dosing regimen in critically ill patients. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Nusrat Shafiq 
Designation  Professor 
Affiliation  Postgraduate institute of medical education and research (PGIMER), Chandigarh 
Address  Room no. 4017, Department of Pharmacology, 4th floor, Research Block b, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9478000822  
Fax    
Email  nusrat.shafiq.pgi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Nusrat Shafiq 
Designation  Professor 
Affiliation  Postgraduate institute of medical education and research (PGIMER), Chandigarh 
Address  Room no. 4017, Department of Pharmacology, 4th floor, Research Block b, PGIMER, Chandigarh


CHANDIGARH
160012
India 
Phone  9478000822  
Fax    
Email  nusrat.shafiq.pgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Samir Malhotra 
Designation  Professor & Head 
Affiliation  Postgraduate institute of medical education and research (PGIMER), Chandigarh 
Address  Room no 4001, Department of Pharmacology, 4th floor, Research Block b, PGIMER, Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9417016343  
Fax    
Email  smal.pgi@gmail.com  
 
Source of Monetary or Material Support  
Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh 
 
Primary Sponsor  
Name  Prof Nusrat Shafiq 
Address  Room no. 4017, Department of Pharmacology, 4th Floor, Research block B, PGIMER, Chandigarh 
Type of Sponsor  Other [Self] 
 
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 
Prof Nusrat Shafiq  Post Graduate Institute of Medical Education and Research  Room no.4017, Fourth floor, Research Block B, Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH 		 9478000822

nusrat.shafiq.pgi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B958||Unspecified staphylococcus as thecause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Vancomycin 1 gm  The patients on comparator arm will be receiving 1 gm of Vancomycin 2 times daily intravenously at an interval of 12 hours for a period of 5 days. 
Intervention  Vancomycin 500 mg  The patients on intervention arm will be given 500 mg of Vancomycin 4 times daily intravenously at an interval of 6 hours for a period of 5 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Critically ill adults admitted to intensive care unit or emergency ward where intravenous vancomycin therapy is deemed necessary based on suspected or confirmed infectious aetiology.
 
 
ExclusionCriteria 
Details  Patients less than 18 years.
Patients requiring renal replacement therapy.
Patients with end stage renal disease.
Patients with end stage hepatic failure.
Any contraindication or history of hypersensitivity with use of vancomycin.
Pregnant and lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients achieving AUC 0-24 hours/MIC ratio more than 400 in both the treatment groups.  Time points considered will be 15 minutes, 30 minutes, 2 hours, 6 hours, 23.5 hours after administration of dose. 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients achieving trough concentration of 15-20 in both the treatment groups.  Second day after starting therapy. 
Proportion of patients alive at the end of treatment in both the treatment groups.  5 days of therapy. 
Proportion of clinical failure at the end of treatment in both the treatment groups.  5 days of therapy. 
To compare the frequency of patient readmission between the treatment groups.  At the end of 28 days. 
Proportion of patients alive at Day 28 in the treatment groups.  At the end of 28 days. 
Proportion of patients requiring substitution of or addition to vancomycin with other antibiotics for the same indication.  5 days of therapy. 
Number of days from vancomycin initiation to intensive care unit discharge.  5 days of therapy. 
Duration of vasopressor support.  5 days of therapy. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   07/02/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary   A study to compare efficacy, safety, pharmacokinetic and pharmacodynamic parameters between conventional dosing regimen and optimised or alternate dosing regime in critically ill patients is planned to be carried out in our institute. We are comparing 1gram twice daily with 500 milligram four times daily. Vancomycin when administered at a dose of 1 gram twice daily may not reach adequate therapeutic concentration in serum as has been shown by a previous study done in our institute. So by this study we are planning to estimate the target concentration attainment of vancomycin in blood and to check if it leads to therapeutic efficacy, reduced mortality, reduction in treatment failure. The study is planned as a two arm parallel open label randomised control trial followed by single arm validation study. The allocation ratio is 1:1. The study will be conducted in Intensive care unit and Emergency wards in PGIMER, Chandigarh. The ethical clearance for this study has been obtained. Informed consent will be taken from the patients or legal attendants before enrolment in the study. 
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