| CTRI Number |
CTRI/2024/07/071374 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the prevalence of gut bacteria in stool of humans and poultry, and in drinking water sources, and compare their antibiotic response, thereby establishing the significance of the One Health concept |
|
Scientific Title of Study
|
Approaching One Health concept through assessing presence of faecal carbapenem-resistant Enterobacterales in humans, farm poultry and water |
| 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 Anwesh Pattanaik |
| Designation |
Post-graduate resident (1st year) |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology,
Room no.39, first floor,
Pathology Block,
Maulana Azad Medical College,
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
7873782458 |
| Fax |
|
| Email |
anwesh95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhav Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology,
Room no. 124A, first floor,
Pathology Block,
Maulana Azad Medical College,
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9899303626 |
| Fax |
|
| Email |
prabhavaggarwal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhav Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Microbiology,
Room no. 124A, first floor,
Pathology Block,
Maulana Azad Medical College,
Bahadur Shah Zafar Marg
Central
DELHI
110002
India |
| Phone |
9899303626 |
| Fax |
|
| Email |
prabhavaggarwal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College,
Bahadur Shah Zafar Marg,
New Delhi, India - 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 Anwesh Pattanaik |
Maulana Azad Medical College and associated hospitals |
Department of Microbiology,
Pathology Block,
Maulana Azad Medical College,
Bahadur Shah Zafar Road
Central
DELHI |
7873782458
anwesh95@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 |
| Healthy Human Volunteers |
Individuals with no antibiotic history over the past 2-3 months |
| Patients |
(1) ICD-10 Condition: Z000||Encounter for general adult medical examination, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults from community who have not received any known antibiotic for at least six months.
2. Adult patients admitted in Medicine wards / ICU who are currently on carbapenem therapy.
3. Fully grown broilers from commercial farms / markets
|
|
| ExclusionCriteria |
| Details |
Individuals with any known gastro-intestinal illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Proportion of faecal carriage of carbapenem-resistant Enterobacterales (CRE) in community, hospitalized patients and poultry, as well as their presence in supply water will be known.
2. The antimicrobial resistance patterns of the isolated CRE will be compared.
|
At baseline only
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Type of carbapenemase enzymes & the genes encoding them in the isolated strains will be known |
At baseline only |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
14/08/2024 |
| 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="2"
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
|
The aim of this study is to determine the presence of
faecal carbapenem-resistant
Enterobacterales in humans, farm poultry
and water, by collecting the stool samples of humans (from the community and
admitted patients), stool samples of poultry, and supply drinking water samples
from the community and in and around our hospital. Following that, the
antimicrobial resistance patterns of all Enterobacterales strains isolated from
the collected samples would be studied. From the patterns thus obtained, a
correlation between them would be established to ascertain the fundamental concepts
of One Health. |