| CTRI Number |
CTRI/2024/09/073419 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Correlation of Clinical Pulmonary Infection Score with Bacterial Etiology in Ventilator-Associated Pneumonia |
|
Scientific Title of Study
|
Analyze a correlation of clinical pulmonary infection score with bacterial etiology in ventilator associated pneumonia with special reference to multi drug resistance and virulence marker in 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 Kaushik Kumar Sahoo |
| Designation |
Junior Resident |
| Affiliation |
|
| Address |
Department of Microbiology Jawaharalal Nehru Medical College DMIHER Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7735056454 |
| Fax |
|
| Email |
sahoo.kaushik1011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Supriya Meshram |
| Designation |
Associate Professor |
| Affiliation |
Jawaharalal Nehru Medical College DMIHER Sawangi Meghe Wardha |
| Address |
Department of Microbiology Jawaharalal Nehru Medical College DMIHER Sawangi Meghe Wardha 442001 India
Wardha
MAHARASHTRA
442001
India |
| Phone |
8605916435 |
| Fax |
|
| Email |
dr.supriya.meshram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushik Kumar Sahoo |
| Designation |
Junior Resident |
| Affiliation |
|
| Address |
Department of Microbiology Jawaharalal Nehru Medical College DMIHER Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7735056454 |
| Fax |
|
| Email |
sahoo.kaushik1011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research 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 Kaushik Kumar Sahoo |
Acharya Vinoba Bhave Rural Hospital |
Dept. of Microbiology,Room No 23, Sawangi Meghe 442001
Wardha
MAHARASHTRA |
7735056454
sahoo.kaushik1011@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 |
(1) ICD-10 Condition: J988||Other specified respiratory disorders, (2) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted and put on mechanical ventilation in ICU for more than 48 hours were included.
Patient having acute respiratory distress syndrome (ARDS).
|
|
| ExclusionCriteria |
| Details |
Patients with pneumonia prior to mechanical ventilation or before 48 hours of mechanical ventilation were excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical Pulmonary Infection Scoring (CPIS), Molecular Method for detection of Carbapenem Resistance for genotype assessment |
1 Year for all data collection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NA |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
01/10/2024 |
| 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="2"
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
|
This is a protocol for planning of the study therefore no data been taken so for,hence no publication |