| CTRI Number |
CTRI/2024/06/068669 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To check methods of testing colistin resistance in gram negative bacteria which are resistant to many drugs |
|
Scientific Title of Study
|
Evaluation of colistin resistance screening methods for detection of colistin resistance in multidrug resistant gram negative bacteria |
| 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. Ngilyang Munya |
| Designation |
Post Graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Microbiology Department, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
08587916985 |
| Fax |
|
| Email |
ngilyang.munya.munya@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 |
Microbiology Department, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9811349053 |
| Fax |
|
| Email |
sonalsaxena3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sonal Saxena |
| Designation |
Director Professor & Head of Department |
| Affiliation |
Maulana Azad Medical College |
| Address |
Microbiology Department, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9811349053 |
| Fax |
|
| Email |
sonalsaxena3@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, New Delhi-110002, India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Microbiology Department, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002 |
| Type of Sponsor |
Government medical college |
|
|
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 Ngilyang Munya |
Maulana Azad Medical College |
Room no.19, Microbiology Department, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi-110002
Central
DELHI |
08587916985
ngilyang.munya.munya@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: B962||Escherichia coli [E. coli ] as thecause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All the isolates from the clinical samples received in the department i.e. pus, sterile body fluids, blood, urine and cerebrospinal fluid that are identified as member of Enterobacterales (except those which are intrinsically resistant), Pseudomonas and Acinetobacter species and are detected as multidrug resistant. |
|
| ExclusionCriteria |
| Details |
Any repeat isolate from the same patient.
Any isolate that are not multidrug resistant. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Performance characteristics of various methods for evaluation of colistin susceptibility in Multidrug resistant Gram negative organisms. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial resistance profiles for common antimicrobials among multidrug resistant gram-negative bacteria. |
1 year |
|
|
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)
|
18/06/2024 |
| 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
|
My study will be conducted in Microbiology Department, Maulana Azad Medical College, New Delhi. The aim of my study is "Evaluation of Colistin Resistance screening methods for detection of colistin resistance in Multidrug Resistant Gram negative bacteria". Different methods will be applied both which are already recommended like broth microdilution, agar dilution etc. and which are comparatively newer like colistin-EDTA agar spot test . |