FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2026/03/105167 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 02/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal Observational Study 
Study Design  Single Arm Study 
Public Title of Study   To see how useful pancreatic stone proteins are as biomarker to detect sepsis early and compare it with ESR and CRP biomarkers 
Scientific Title of Study   Efficacy of pancreatic stone proteins in early diagnosis of sepsis and comparison of its temporal trends with ESR and CRP - A longitudinal observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Paras Singh 
Designation  Paediatric Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8279462359  
Fax    
Email  paras.singh929315@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tanmaya Metgud 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9845395294  
Fax    
Email  tanmayametgud@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Paras Singh 
Designation  Paediatric Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8279462359  
Fax    
Email  paras.singh929315@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Nehru Nagar, Belgaum, Karnataka, India - 590010 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College  
Address  Department of Paediatrics, Jawaharlal Nehru Medical College and KLEs Dr Prabhakar Kore Hospital and Medical Research Center, Nehru Nagar, Belagavi 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Paras Singh  Dr Prabhakar Kore Hospital and Medical Research Center  Paediatric Emergency, 3rd Floor, Department of Paediatrics
Belgaum
KARNATAKA 
8279462359

paras.singh929315@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Children aged 1 month to 18 years admitted to specified units presenting with sepsis symptoms per the International Paediatric Sepsis Consensus Conference (IPSCC) guidelines - 2024, which recommends that sepsis can be identified in children with a phoenix sepsis score of more than 2 or, sepsis confirmed by a positive blood culture isolate. 
 
ExclusionCriteria 
Details  1. Patients with functional disorders unrelated to sepsis (autoimmune disorders, malignancies, non-infectious SIRS causes)
2. Patients with surgery in past 6 months.
3. Patients with underlying renal, cardiac or hepatic failure. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Diagnostic efficacy of Pancreatic Stone Proteins for early sepsis detection   Day 1, Day 3, Day 5 
 
Secondary Outcome  
Outcome  TimePoints 
Pancreatic Stone Proteins trend vs ESR and CRP  Day 1, Day 3, Day 5 
Correlation of PSP with positive blood cultures.   
Association of PSP with outcomes (organ failure, mortality)   
 
Target Sample Size   Total Sample Size="53"
Sample Size from India="53" 
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)   20/03/2026 
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="0"
Months="10"
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 - NO
Brief Summary  

WHO defines sepsis a life-threatening condition that arises when the body’s response to infection causes injury to its own tissues and organs. Sepsis remains a significant cause of morbidity and mortality in the paediatric population. Early detection is crucial for effective management, prompting ongoing research into reliable biomarkers. Traditionally, biomarkers such as Erythrocyte Sedimentation Rate (ESR) and C- Reactive Protein (CRP) have been utilised, but their specificity and sensitivity limitations have led to the exploration of novel indicators like Pancreatic Stone Proteins (PSP). Pancreatic stone protein (PSP), a C-type lectin protein, is a well-defined biomarker of sepsis. PSP activates polymorphonuclear neutrophils (PMNs) and aggravates multiple organ dysfunction syndrome. PSP levels are correlated with disease severity, vasopressor support, progression to organ failure, mechanical ventilation, renal replacement therapy, length of stay, and mortality. As PSP is a C-type lectin protein, it may have a role in activating innate immunity through the C-type lectin receptors (CLRs) of the study. Through this study, we aim to evaluate the diagnostic value of PSP in Indian paediatric age group, its evolving levels throughout the course of the disease and how it compares to other pre-existing markers. Existing biomarkers have proven to have a variable sensitivity in early course of sepsis, with their elevation observed in non-septic SIRS as well. There is a wide knowledge gap in early detection of sepsis, with the only diagnostic modality being a positive blood culture. As a confimatory blood culture requires a standard incubation time of 5 days, to develop a diagnostic test for confirmation of sepsis onset early on becomes pivotal in improving the existing prognostic outcomes.

 
Close