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CTRI Number  CTRI/2024/07/071620 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 29/07/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Molecular determinants determining Ceftaroline resistance in isolates of Methicillin-Resistant Staphylococcus Aureus identified within routine clinical samples 
Scientific Title of Study   Molecular determinants for Ceftaroline resistance in Clinical Isolates of Methicillin-Resistant Staphylococcus Aureus: A Cross sectional Pilot Study 
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 Gaurav Jain 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Rishikesh  
Address  Department of Anaesthesiology, Level 6, All India Institute of Medical Sciences Rishikesh, Virbhadra Marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8808631209  
Fax    
Email  gauravhld@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gaurav Jain 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Rishikesh  
Address  Department of Anaesthesiology, Level 6, All India Institute of Medical Sciences Rishikesh, Virbhadra Marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8808631209  
Fax    
Email  gauravhld@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gaurav Jain 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences Rishikesh  
Address  Department of Anaesthesiology, Level 6, All India Institute of Medical Sciences Rishikesh, Virbhadra Marg, Rishikesh

Dehradun
UTTARANCHAL
249203
India 
Phone  8808631209  
Fax    
Email  gauravhld@gmail.com  
 
Source of Monetary or Material Support  
Critical care unit and Department of Microbiology, AIIMS Rishikesh, Virbhadra Marg, Rishikesh, Dehradun, Uttarakhand, India-249203  
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Rishikesh 
Address  Virbhadra Marg, Rishikesh, Dehradun, UTTARANCHAL 249203 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 
Dr Gaurav Jain  AIIMS Rishikesh  Critical Care unit, level 6, and Department of Microbiology, level 4, AIIMS Rishikesh Dehradun UTTARANCHAL
Dehradun
UTTARANCHAL 		 8808631209

gauravhld@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B956||Staphylococcus aureus as the causeof diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Clinical samples found to be Methicillin-Resistant Staphylococcus aureus positive obtained from patients of age group more than one years of age, of either gender, admitted to various clinical departments  
 
ExclusionCriteria 
Details  Patients/relatives inability or refusal for consent  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Molecular determinants contributing to Ceftaroline resistance in Clinical Isolates of Methicillin-Resistant Staphylococcus aureus (10 ceftaroline sensitive, 10 ceftaroline resistant) using next generation sequencing  At baseline, on identifying Methicillin-Resistant Staphylococcus aureus isolates within routine clinical samples reaching the lab for microbiological & sensitivity analysis 
 
Secondary Outcome  
Outcome  TimePoints 
Antimicrobial susceptibility pattern of identified Methicillin-Resistant Staphylococcus aureus isolates with respect to Ceftaroline sensitivity  At baseline, on identifying Methicillin-Resistant Staphylococcus aureus isolates within routine clinical samples reaching the lab for microbiological & sensitivity analysis 
Baseline patient parameters including demographics, patient location, baseline diagnosis, co-morbidities, any risk factors, cannulation, type of sample  At baseline, on identifying Methicillin-Resistant Staphylococcus aureus isolates within routine clinical samples reaching the lab for microbiological & sensitivity analysis 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   10/08/2024 
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="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 - NO
Brief Summary   Methicillin-resistant Staphylococcus aureus (MRSA) infection poses a significant public health challenge. Despite efforts to control its spread, MRSA continues to cause a substantial burden of morbidity and mortality worldwide. The emergence of community-acquired MRSA strains further complicates the issue. β-lactam antibiotics have historically been frontline treatments for staphylococcal infections. However, the rise of β-lactam resistance in MRSA strains renders these antibiotics ineffective, limiting treatment options and increasing the risk of treatment failure, persistent infections, and adverse patient outcomes. Thus, healthcare providers are compelled to turn to second-line agents, such as vancomycin, daptomycin, or linezolid. However, these alternatives may be associated with drawbacks such as reduced potency due to slow rate of bactericidal activity, bacteriostatic effect or poor tissue penetration, higher rates of adverse effects and increased risk of developing resistance over time. Ceftaroline is a fifth-generation cephalosporin is a promising treatment option for MRSA infections due to its unique mechanism of action and broad spectrum of activity.  

Next generation sequencing is a powerful tool to compare the whole genomes and analyze the single base pair variations and polymorphisms (SNPs) found within the antibiotic resistant genes. Previous literature shows an antimicrobial susceptibility rate of 95% for Ceftaroline among the clinical MRSA isolates. Literature is however, limited especially in Indian scenario. Accounting for possible emergence of antimicrobial Ceftaroline resistance among MRSA isolates, we aim to conduct a pilot study as a part of future comprehensive trial that may identify the possible molecular determinants (known and unknown) contributing to Ceftaroline resistance in MRSA isolates identified within clinical samples obtained from admitted patients in our tertiary care hospital. 
 
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