| CTRI Number |
CTRI/2025/12/098248 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of flow cytometry in differentiating between the body’s first line of defense (innate immunity) and its learned defense (adaptive immunity) in children. |
|
Scientific Title of Study
|
Role of flow cytometry in distinguishing between innate immunity and adaptive immunity using (m)CD169 and (n)CD64 in paediatric population. |
| 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 Daksha Suthar |
| Designation |
Post graduate resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
Delhi
Central DELHI 110002 India |
| Phone |
9602964970 |
| Fax |
|
| Email |
dakshme13@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sarika Singh |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
Delhi
Central DELHI 110002 India |
| Phone |
9911182326 |
| Fax |
|
| Email |
sarikasingh97b@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sarika Singh |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no. 54, Department of Pathology, Pathology block, Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg
Central
Delhi
Central DELHI 110002 India |
| Phone |
9911182326 |
| Fax |
|
| Email |
sarikasingh97b@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
2, Bahadur Shah Zafar Marg, New Delhi, 110002 |
| Type of Sponsor |
Government 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 Daksha Suthar |
Maulana Azad Medical College |
Room no. 54, Department of Pathology, Pathology Block, 2 Bahadur Shah Zafar Marg Central DELHI |
9602964970
dakshme13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospital (Lok Nayak, G.I.P.M.E.R., Guru Nayak Eye Centre, New Delhi-110002) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
All paediatric patients in the department of Paediatrics of 01 month to 05 years of age who present to OPD or emergency department within 05 days of acute infective illness, with any or all symptoms like cold, cough, coryza, wheeze, fever, myalgia, arthralgia, rashes, diarrhoea, vomiting and headache, with having no prior antibiotic intake when presenting to the OPD or the Emergency wards. |
|
| ExclusionCriteria |
| Details |
1. Patients presenting with any etiology other than infections.
2. Patients presenting with chronic infections, Tubercular, Malarial and Fungal infections.
3. Patients who have received antibiotics. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of cells expressing mCD169 and nCD64 in monocytes and neutrophils by flow cytometry in paediatric population in infections. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Correlation of mCD169 with innate immune response for viral infections and nCD64 with adaptive immune response for bacterial infections using various parameters: 1)ELISA, PCR, Cultures. 2) C Reactive protein, Procalcitonin, LDH. 3) Total leukocyte count, Absolute Neutrophil and Absolute Lymphocyte count. |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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)
|
31/12/2025 |
| 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 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
|
The immune system protects the body through two main
mechanisms — innate and adaptive immunity. Innate immunity
provides the first line of defense using cells like monocytes, macrophages,
dendritic cells, and natural killer cells, while adaptive immunity
involves T cells, B cells, and antibodies, which provide memory
and specificity.
Monocytes play a key role in recognizing infections
and can differentiate into macrophages. Two important surface markers, CD169
and CD64, are used to study immune responses. CD169 is upregulated
during viral infections and autoimmune conditions, while CD64
increases during bacterial infections. These biomarkers help distinguish
between infection types.
Data from the National Family Health Survey- 5 shows
improvement in infant and child mortality rates in India compared to NFHS-4,
though issues like low birth weight and infectious diseases like pneumonia,
diarrhea, malaria, remain major causes of death in children under five.
Accurate diagnosis of infections is crucial to reduce antimicrobial
resistance caused by excessive antibiotic use. Traditional methods like blood
culture are reliable but slow, so newer markers such as Procalcitonin and
C-Reactive Protein, along with leukocyte counts and morphological
changes, are used.
A recent study demonstrated that CD64 on neutrophils
(nCD64) rises in bacterial infections, while CD169 on monocytes (mCD169)
rises in viral infections. These biomarkers show high sensitivity and
specificity, making them valuable tools for rapid infection triage and antibiotic
stewardship in clinical and epidemic settings. |