| CTRI Number |
CTRI/2026/01/100303 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Morphological Patterns of Hospital Acquired Pneumonia and Associated Carbapenem Resistance in Bacterial Pathogens |
|
Scientific Title of Study
|
Microbiological Profile of Hospital Acquired Pneumonia with Detection of Carbapenem Resistance in Bacterial Isolates in a Tertiary Care Hospital |
| 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 Dhivya Rajendran |
| Designation |
MD Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem. |
| Address |
PG room, Department of Microbiology, Vinayaka Missions Kirupananda Variyar medical College and Hospitals, Salem.
PG room, Department of Microbiology, Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Sankari Main Road,Seeragapadi, Salem.
Salem
TAMIL NADU
636308
India |
| Phone |
9962258637 |
| Fax |
|
| Email |
dhivyarajendran1402@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mathavi S |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem. |
| Address |
Department of Microbiology,
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Sankari Main Road,Seeragapadi, Salem.
Salem
TAMIL NADU
636308
India |
| Phone |
9600251333 |
| Fax |
|
| Email |
drmathavimicro@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhivya Rajendran |
| Designation |
MD Post Graduate |
| Affiliation |
Vinayaka Missions Kirupananda Variyar Medical College and Hospitals, Salem. |
| Address |
PG room, Department of Microbiology, Vinayaka Missions Kirupananda Variyar medical College and Hospitals, Salem.
Salem
TAMIL NADU
636308
India |
| Phone |
9962258637 |
| Fax |
|
| Email |
dhivyarajendran1402@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Dhivya Rajendran |
| Address |
PG Room, Department of Microbiology, Vinayaka Missions Kirupananda Variyar medical College and Hospitals, Salem, 636308. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Dhivya Rajendran |
Vinayaka Missions kirupananda Variyar Medical College and Hospitals |
Fisrt floor, Microbiology laboratory, Vinayaka Missions kirupananda Variyar Medical College and Hospitals, Seeragapadi, Salem, 636308.
Salem
TAMIL NADU |
9962258637
dhivyarajendran1402@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| 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: J189||Pneumonia, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with Hospital Acquired Pneumonia after 48 hours of Hospital Admission.
2.Patient with clinical signs of Hospital Acquired Pneumonia (Fever, cough and Purulent sputum) who was admitted to the intensive care unit or ward. |
|
| ExclusionCriteria |
| Details |
Patient with Community Acquired Pneumonia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To isolate and identify pathogen causing Hospital Acquired Pneumonia and aid for effective empiric treatment guidelines. |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
15/01/2026 |
| 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
|
This is a cross sectional, open labelled study on detecting the morphological profile of hospital acquired pneumonia with carbapenem resistant bacterial isolates obtained through respiratory samples by conventional , phenotypic and genotypic method in a tertiary care hospital, salem, TamilNadu, India and to aid empirical antibiotic treatment guidelines. |