| CTRI Number |
CTRI/2025/04/084670 [Registered on: 13/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pneumonia and its indices to compare for morbidity and mortality |
|
Scientific Title of Study
|
Comparative Study of CURB-65 and Pneumonia Severity Index(PSI) as prognostic marker for patients with Community Acquired Pneumonia(CAP) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Palak Manoj Agrawal |
| Designation |
Resident doctor |
| Affiliation |
D Y Patil School Of Medicine Deemd to be University, Navi Mumbai |
| Address |
D Y Patil hospitat , Department of Medicine 3rd floor,room no 3,sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
7999850150 |
| Fax |
|
| Email |
palakagr1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santwana Chandrakar |
| Designation |
Head of department |
| Affiliation |
D Y Patil School Of Medicine Deemd to be University, Navi Mumbai |
| Address |
D Y Patil hospital, medicine division, department of medicine ,3rd floor ,sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
9820505489 |
| Fax |
|
| Email |
santwana.chandrakar@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Palak Manoj Agrawal |
| Designation |
Resident doctor |
| Affiliation |
D Y Patil School Of Medicine Deemd to be University, Navi Mumbai |
| Address |
D Y Patil hospital ,medicine division, medicine department,3rd floor,Ayyappa nagar ,sector 5, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400701
India |
| Phone |
7999850150 |
| Fax |
|
| Email |
palakagr1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| D Y Patil hospital ,sector 5,Nerul,ayappa nagar,Navi Mumbai-400701, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
D Y Patil Hospital |
| Address |
D Y Patil hospital ,sector 5, Ayyappa nagar,Nerul,Navi Mumbai-400701, Maharashtra , India |
| 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 |
| DrPalak agrawal |
D Y Patil Hospital |
D Y Patil Hospital,sector 5, Ayyappa nagar, Nerul, Navi Mumbai
Thane
MAHARASHTRA |
7999850150
palakagr1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with symptoms,signs and radiological evidence suggestive of lower respiratory tract infection.
2.Above age of 18 years |
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years.
2.Patient not giving consent.
3. Patients having TB or malignancy.
4.Acute Coronary syndromes,pregnant females, pulmonary edema.
5. Hospital acquired infection,immunocompromised patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
CURB 65 score
PSI score |
Baseline
4 weeks
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Icu admissions
Morbidity and mortality |
Baseline
6 months |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
04/05/2025 |
| 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 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
|
To compare the 2 score-CURB-65 and PSi in pneumonia patients and it’s relative correlation to mortality in admitted patients. Purpose of trial is to avoid unnecessary burden over the medical system and prevent wastage of resources |