| CTRI Number |
CTRI/2025/10/096053 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of how cells,like microbes stop responding to medicine that to work on bacteria spread in the intensive care unit of a big hospital |
|
Scientific Title of Study
|
Molecular epidemiology of carbapenemase producing Enterobacterales in Medicine intensive care unit of tertiary health care center |
| 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 Kendre Sonali Sambahaji |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Microbiology, 2nd Floor, JNMC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096373566 |
| Fax |
|
| Email |
shrikantsonaliaarya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gargi Mudey |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Microbiology, 2nd Floor, JNMC Building, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860265849 |
| Fax |
|
| Email |
gargimudey@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gargi Mudey |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Microbiology, 2nd Floor, JNMC Building, Sawangi Meghe
MAHARASHTRA
442001
India |
| Phone |
9860265849 |
| Fax |
|
| Email |
gargimudey@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi Meghe, Wardha, India, 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe, Wardha, India, 442001 |
| Type of Sponsor |
Private 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 Sonali Kendre |
Jawaharlal Nehru Medical College |
Dept of Microbiology, 2nd Floor, JNMC Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9096373566
shrikantsonaliaarya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinical isolates of E. coli and Klebsiella spp. received in the dept of Microbiology
during study period
2. Stool samples/Rectal swabs of HCWs and patients will be collected from MICU
3. Environmental sampling of MICU will be performed at intervals to detect the
probable source of CPE (E. coli and Klebsiella spp.) in hospital environment |
|
| ExclusionCriteria |
| Details |
1.Clinical isolates sensitive & intermediate to Imipenem, Meropenem and Ertapenem
will be excluded from the study
2. Patients and HCWs not willing to participate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insight into source of infection and transmission patterns and antibiotic susceptibility pattern. |
Assessment will be done at 2 weeks and 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="490"
Sample Size from India="490"
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)
|
01/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Carbapenemase-producing Enterobacterales (CPE) are a subset of CRE that create carbapenemases enzymes by degrading carbapenems and similar antibiotics, rendering them ineffective. This study is planned to know the molecular epidemiology of CPE in Medicine ICU (MICU) of a tertiary health care center. So, the data will be useful for planning hospital infection control strategies and antimicrobial stewardship programs. This will be a cross-sectional study that will be conducted in JNMC, wardha, India. About 490 samples will be tested. |