| CTRI Number |
CTRI/2025/09/094523 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Causes of Childhood Dysentery and Antimicrobial Resistance pattern in Shigella species. |
|
Scientific Title of Study
|
Etiology of Childhood Dysentery and Characterisation of Antimicrobial Resistance in Shigella. |
| 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 Rashmi |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number 39, Department of Microbiology, Pathology Block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9315749544 |
| Fax |
|
| Email |
Reachrashmi06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhav Aggarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room Number 124A, Department of Microbiology, Pathology Block, Maulana Azad Medical College, New Delhi
Central
DELHI
110002
India |
| Phone |
9899303626 |
| Fax |
|
| Email |
prabhavaggarwal@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prabhav Aggarwal |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
ROOM NUMBER 124A, DEPARTMENT OF MICROBIOLOGY, PATHOLOGY BLOCK, MAULANA AZAD MEDICAL COLLEGE, NEW DELHI
Central
DELHI
110002
India |
| Phone |
9899303626 |
| Fax |
|
| Email |
prabhavaggarwal@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi 110002 India |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Microbiology Maulana Azad Medical College New Delhi 110002 India |
| 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 Rashmi |
Maulana Azad Medical College |
Department Of Microbiology, Pathology block, Maulana Azad Medical College
Central
DELHI |
9315749544
Reachrashmi06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A039||Shigellosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
50 Fresh Fecal Samples from children presenting with dysentery.
De-identified and archived Shigella isolates from previous two years from pediatric stool samples. |
|
| ExclusionCriteria |
| Details |
CHILDREN WITH KNOWN CAUSES OF BLOOD IN STOOLS.
DE-IDENTIFIED AND ARCHIVED SHIGELLA ISOLATES THAT FAIL TO GET REVIVED FROM STOCK CULTURES. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Proportions of Shigella spp. and other enteropathogens responsible for childhood
dysentery
|
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Antimicrobial susceptibility patterns of Shigella isolates will be known |
1 year |
| Proportion & types of extended spectrum beta lactamases in Shigella will be known. |
1 year |
| The trends of antimicrobial susceptibility pattern & extended spectrum beta lactamases carriage in Shigella isolates over the current & preceding two years will be known |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
20/09/2025 |
| 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="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
|
The study entitled "Etiology of childhood dysentery and characterisation of Antimicrobial Resistance in Shigella" will be conducted at Department of Microbiology, Maulana Azad Medical College in collabration with Department of Pediatrics, Maulana Azad Medical College and associated Lok Nayak Hospital. Only after proper consent stool samples will be taken for Culture, AST, Serotyping and PCR. |