| 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
|
|
|
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
|
|
|
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. |