| CTRI Number |
CTRI/2026/03/106537 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective |
| Study Design |
Other |
|
Public Title of Study
|
Use of CRP test in detecting serious infections in children aged 1–36 months with fever |
|
Scientific Title of Study
|
Study of C-reactive protein in acute febrile illness in children aged 1 to 36 months |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pasam Chandra Sahith Reddy |
| Designation |
Junior resident |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
| Address |
Department of Paediatrics, Jwaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8639125040 |
| Fax |
|
| Email |
chandrasahith1103@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHISH VARMA |
| Designation |
professor |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
| Address |
Department of Paediatrics, Jwaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9860500063 |
| Fax |
|
| Email |
avarma2055@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pasam Chandra Sahith Reddy |
| Designation |
Junior resident |
| Affiliation |
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION & RESEARCH |
| Address |
Department of Paediatrics, Jwaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8639125040 |
| Fax |
|
| Email |
chandrasahith1103@gmail.com |
|
|
Source of Monetary or Material Support
|
| JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI MEGHE, WARDHA, 442001 |
|
|
Primary Sponsor
|
| Name |
JNMC |
| Address |
SAWANGI MEGHE, WARDHA, MAHARASTRA, 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 PASAM CHANDRA SAHITH REDDY |
ACHARYA VINOBHA BHAVE RURAL HOSPITAL |
WARD 16-18, DEPARTMENT OF PAEDIATRICS, JAWAHARLAL NEHRU MEDICAL COLLEGE, SAWANGI MEGHE, WARDHA
Wardha
MAHARASHTRA |
8639125040
chandrasahith1103@gmail.com |
|
|
Details of Ethics Committee
|
| 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: R508||Other specified fever, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
36.00 Month(s) |
| Gender |
Both |
| Details |
presenting fever with more than 37.9 celsius of less than 8 days duration |
|
| ExclusionCriteria |
| Details |
known immunodeficiencies |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of C-reactive protein (CRP) in detecting serious bacterial infections in children aged 1–36 months with acute febrile illness. |
CRP measured at baseline (at presentation) and outcome assessed at time of final diagnosis during hospital stay. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="165"
Sample Size from India="165"
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)
|
31/03/2026 |
| 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="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 prospective observational study aims to evaluate the role of C-reactive protein (CRP) as a diagnostic marker for identifying serious bacterial infection (SBI) in children aged 1–36 months presenting with acute febrile illness. Young children with fever often present without clear localizing signs, making early differentiation between bacterial and viral infections challenging. Early and accurate identification of SBI is crucial to prevent complications and reduce unnecessary antibiotic use.
In this study, CRP levels will be measured at presentation and correlated with definitive clinical and laboratory diagnoses of serious bacterial infection. The diagnostic performance of CRP—including its sensitivity, specificity, and predictive value—will be analyzed to determine its usefulness as an early screening tool in this age group.
The findings may help guide clinical decision-making and improve management strategies for febrile young children. |