| CTRI Number |
CTRI/2025/10/096697 [Registered on: 31/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
This study will check if a blood test called procalcitonin can show how severe pneumonia is when patients are admitted. By measuring this level, we hope doctors can detect serious infection early, give timely treatment, and improve patient recovery. |
|
Scientific Title of Study
|
A study to assess the correlation between procalcitonin values with severity of bacterial community-acquired pneumonia patients admitted in tertiary care hospital,Udupi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sayanti Pattanayak |
| Designation |
Nurse Practitioner Student |
| Affiliation |
Manipal College Of Nursing, Manipal |
| Address |
Department Of Medical Surgical Nursing, Manipal College Of Nursing, Manipal Academy Of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7483732564 |
| Fax |
|
| Email |
Sayanti.mconmpl2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Janet Alva |
| Designation |
Assistant professor |
| Affiliation |
Manipal College Of Nursing, Manipal |
| Address |
Department Of Medical Surgical Nursing, Manipal College Of Nursing, Manipal Academy Of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845646725 |
| Fax |
|
| Email |
janet.a@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Janet Alva |
| Designation |
Assistant professor |
| Affiliation |
Manipal College Of Nursing, Manipal |
| Address |
Department Of Medical Surgical Nursing, Manipal College Of Nursing, Manipal Academy Of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845646725 |
| Fax |
|
| Email |
janet.a@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College Of Nursing, Manipal, Manipal Academy Of Higher Education, Manipal,Udupi,Karnataka, India,576104 |
|
|
Primary Sponsor
|
| Name |
Sayanti Pattanayak |
| Address |
Department Of Medical Surgical Nursing, Manipal College Of Nursing, Manipal Academy Of Higher Education, Manipal |
| 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 Sagar MS |
Kasturba Hospital, Manipal |
Department Of Critical Care Medicine manipal, udupi, karnataka,576104
Udupi
KARNATAKA |
9764391100
sagar.ms@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College And Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J13||Pneumonia due to Streptococcus pneumoniae, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion Criteria
adult patients are above 18 years
has developed symptoms within 48 hours of admission and has no history of hospitalization in last 14 days
elevated procalcitonine level more than 0.5 |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria
patient age more than 18 years
patients who has history of hospitalization within 14 days
patient with hospital acquired pneumonia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary outcomes
-correlation between procalcitonin and CURB-65/PSI
-Correlation between procalcitonin and inflammatory markers |
48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mortality, ventilator free days |
1 week |
|
|
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)
|
10/11/2025 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (lipcy1998@gmail.com).
- For how long will this data be available start date provided 01-11-2025 and end date provided 27-12-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective cross sectional study aims to assess the correlation between serum procalcitonin levels and disease severity in patients with bacterial community acquired pneumonia admitted to Kasturba Hospital Manipal from May 2025 to July 2026. A total of 100 adult patients aged 18 years and above with symptom onset within 48 hours of admission and elevated procalcitonin levels greater than 0.5 ng per mL will be enrolled using purposive sampling, excluding those with recent hospitalization, hospital acquired or viral pneumonia. Data will be collected through a structured proforma including demographic details, clinical parameters, inflammatory markers such as CRP, WBC and NLR, radiological findings and outcomes. Disease severity will be assessed using CURB 65 and Pneumonia Severity Index scores, and correlations between procalcitonin levels, inflammatory markers and clinical outcomes such as mortality, ventilator free days and ICU stay will be analyzed using descriptive and inferential statistics. The study seeks to determine whether procalcitonin can serve as a reliable biomarker for predicting disease severity and outcomes in community acquired pneumonia, potentially improving patient management, guiding antibiotic therapy and reducing unnecessary antibiotic use. The study involves minimal risk, is self funded with an estimated cost of 13250 INR, and all institutional and ethical approvals will be obtained prior to commencement. |