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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  
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 
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  
Status 
Not Applicable 
 
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.

 
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