| CTRI Number |
CTRI/2025/09/094595 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinicomicrobiological study of ventilator associated pneumonia in a paediatric intensive care unit |
|
Scientific Title of Study
|
A CLINICOMICROBIOLOGICAL STUDY OF VENTILATOR ASSOCIATED PNEUMONIA IN A PAEDIATRIC CRITICAL CARE UNIT |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
TEJSWINI B TELE |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Room no 39, Microbiology Department, pathology block. Maulana Azad medical college. Delhi 110002.
Central
DELHI
110002
India |
| Phone |
9766972884 |
| Fax |
|
| Email |
tejswinibtele@gmail.co m |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Bhanu Mehra |
| Designation |
Assistant Professor |
| Affiliation |
Maulana Azad medical college |
| Address |
Microbiology Department, pathology block. Maulana Azad medical college. Delhi 110002.
Central
DELHI
110002
India |
| Phone |
9810650581 |
| Fax |
|
| Email |
bhanu.mb86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TEJSWINI B TELE |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad medical college |
| Address |
Room no 39, Microbiology Department, pathology block. Maulana Azad medical college. Delhi 110002.
Central
DELHI
110002
India |
| Phone |
9766972884 |
| Fax |
|
| Email |
tejswinibtele@gmail.co m |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical college |
| Address |
Maulana Azad medical college, central 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 Tejswini B Tele |
Maulana Azad Medical College |
Department of Microbiology, Maulana Azad Medical College, Central Delhi 110002
Central
DELHI |
9766972884
tejswinibtele@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICAL COMITTEE, MAULANA AZAD MEDICAL COLLEGE AND ASSOCIATED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y95||Nosocomial condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
All patients between 1 month to 12 years of age who are on mechanical ventilation for more than two consecutive days. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The study would generate data on:
a. Magnitude of ventilator associated pneumonia (VAP) in paediatric critical care unit at Lok Nayak Hospital. |
One year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The study would generate data on:
a. Proportion of isolates of causative bacterial pathogens of ventilator associated pneumonia (VAP) in children admitted in paediatric critical care unit.
b. Percentage of isolates of causative bacterial pathogens of VAP in these children that are susceptible or resistant to the various antibiotics in the panel.
c. The association of risk factors with VAP in these children. |
One year. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/09/2025 |
| 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
|
Given the significant impact of ventilator associated pneumonia (VAP) on patient outcomes, there is growing need for enhanced surveillance and research to better understand its epidemiology, risk factors and microbial patterns. A more comprehensive understanding of the aetiology and pathogenesis of VAP can bridge existing gaps in prevention and treatment strategies, ultimately reducing the burden of this infection in paediatric critical care settings. Thus the study entitled "A CLINICOMICROBIOLOGICAL STUDY OF VENTILATOR ASSOCIATED PNEUMONIA" will be conducted at departments of Microbiology and Paediatrics in Maulana Azad medical college and Lok Nayak hospital. Only after proper consent ventilated patients will be enrolled in the study for the surveillance of VAP. |