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CTRI Number  CTRI/2024/09/074195 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 19/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study colistin resistance in Gram-negative bacteria by performing various phenotypic and genotypic methods 
Scientific Title of Study   Phenotypic Detection and Genotypic Characterization of colistin resistance in Gram-negative bacilli 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha 
Designation  PhD Scholar 
Affiliation  Maulana Azad Medical College 
Address  Maulana Azad Medical College, Department of Microbiology, Pathology Block, Ground Floor, New Delhi

New Delhi
DELHI
110002
India 
Phone  9811093693  
Fax    
Email  manishakaim9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sonal Saxena 
Designation  Director Professor and Head of Department 
Affiliation  Maulana Azad Medical College 
Address  Maulana Azad Medical College, Room No. 19, Department of Microbiology, Pathology Block, Ground Floor, New Delhi

New Delhi
DELHI
110002
India 
Phone  9811349053  
Fax    
Email  sonalsaxena3@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sonal Saxena 
Designation  Director Professor and Head of Department 
Affiliation  Maulana Azad Medical College 
Address  Maulana Azad Medical College, Room No. 19, Department of Microbiology, Pathology Block, Ground Floor, New Delhi

New Delhi
DELHI
110002
India 
Phone  9811349053  
Fax    
Email  sonalsaxena3@gmail.com  
 
Source of Monetary or Material Support  
Department of Microbiology, Room No. 19, Pathology Block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg, India, New Delhi: 110002 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Sonal Saxena  Maulana Azad Medical College  Departmeny of Microbiology, Pathology Block, Room No.19, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI 
9811349053

sonalsaxena3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Day(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Gram-negative bacilli isolated and stocked from any clinical sample routinely submitted for a bacterial culture that tests resistance to colistin by broth microdilution method as well as carbapenem-resistance gram-negative bacteria. 
 
ExclusionCriteria 
Details  Gram-negative bacilli with intrinsic resistance to colistin. 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1. To detect the presence of the mcr-1 gene and its variants in Gram-Negative Bacilli which may lead to low/high-level colistin resistance.
2. To evaluate various phenotypic tests for determining colistin resistance in comparison to Broth Microdilution 
3 YEARS 
 
Secondary Outcome  
Outcome  TimePoints 
1. To determine susceptibility to currently available and newer treatment options as alternatives to colistin
2. To determine genes encoding for Carbapenemase and Extended-Spectrum Beta-Lactamase (ESBLs) 
3 YEARS 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   30/09/2024 
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="3"
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  

Antimicrobial resistance (AMR) is a global health and development threat. World Health Organization (WHO) has declared that AMR is one of the top ten global public health threats facing humanity. Resistance to colistin is steadily rising in Gram-negative bacilli. Hence, there is a need to analyze their resistance profile, and mechanisms and look for alternate treatment options. The primary objectives are to detect the presence of the mcr-1 gene and its variants in Gram-Negative Bacilli which may lead to low/high-level colistin resistance and to evaluate various phenotypic tests for determining colistin resistance in comparison to Broth Microdilution. the secondary objectives are to determine susceptibility to currently available and newer treatment options as alternatives to colistin and to determine genes encoding for Carbapenemase and Extended-Spectrum Beta-Lactamase (ESBLs). The study will be carried out in the Department of Microbiology, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. Stocked Gram-negative bacterial isolates from all clinical specimens routinely submitted for bacterial culture and susceptibility testing will be included in the study. No patient data will be collected. No patient specimen will be collected for the study.

 
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