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CTRI Number  CTRI/2025/12/099998 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 26/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A study on patients with suspected brain infections to identify the microorganisms causing the illness using extended laboratory tests and to study the genetic features of Streptococcus pneumoniae 
Scientific Title of Study   Comprehensive Etiological Profile of Central Nervous System Infections and Genomic Characterization of Streptococcus pneumoniae from a Tertiary Care Centre in Chennai, India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subramanian H 
Designation  PhD Research Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) 
Address  Department of Microbiology, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9884362106  
Fax    
Email  u022401186@sriramachandra.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sribal S 
Designation  Assistant professor 
Affiliation  Sri Ramachandra Medical College and Research Institute 
Address  Department of Microbiology, Sri Ramachandra Medical College and Research Institute, Porur

Chennai
TAMIL NADU
600116
India 
Phone  9884118630  
Fax    
Email  dr.sribal@sriramachandra.edu.in  
 
Details of Contact Person
Public Query  
Name  Subramanian H 
Designation  PhD Research Scholar 
Affiliation  Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) 
Address  Department of Microbiology, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), Chennai

Chennai
TAMIL NADU
600116
India 
Phone  9884362106  
Fax    
Email  u022401186@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Founder – Chancellor Shri. N. P. V. Ramasamy Udayar Research Fellowship, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) 
 
Primary Sponsor  
Name  Subramanian H 
Address  PhD Research Scholar, Department of Microbiology, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University) Chennai, Porur – 600116, Contact number: 9884362106, Email: u022401186@sriramachandra.edu.in 
Type of Sponsor  Other [Self] 
 
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 
Subramanian H PhD Research Scholar Department of Microbiology  Sri Ramachandra Medical Centre and Hospital  1A Molecular Biology Centre and Clinical Virology Section Department of Microbiology, SRMC, No.1 Ramachandra Nagar, Porur.
Chennai
TAMIL NADU 		 9884362106

u022401186@sriramachandra.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G09||Inflammatory diseases of the central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients suspected with meningitis/encephalitis of all age group whose CSF were submitted for microbiological testing.

Residual CSF samples available and sufficient for additional testing which are stored appropriately. 
 
ExclusionCriteria 
Details  Insufficient sample volume for additional testing, and improper storage.

Participants not willing to participate in the research. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Prevalence and etiological profiling of infectious meningitis/encephalitis  Initial CSF sample collection/Diagnostic testing 
 
Secondary Outcome  
Outcome  TimePoints 
Genomic characterization of Streptococcus pneumoniae isolated from the CSF  Upon successful Whole genome sequencing of isolate 
Correlations between routine CSF profiles and molecularly identified pathogens  Initial CSF sample collection/Diagnostic testing 
Provide data on prevailing AMR genes, and non-vaccine serotypes  Upon successful WGS of isolate 
 
Target Sample Size   Total Sample Size="191"
Sample Size from India="191" 
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)   01/01/2026 
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="3"
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 study is a cross sectional observational study which aims to screen the CSF samples of patients with suspected meningitis/encephalitis using multiplex PCR panel tests targeting 30 pathogens to identify the etiological cause and to characterize the genomic profile of Streptococcus pneumoniae isolated from the CSF using whole genome sequencing to understand the genomic shifts, vaccine escape, antimicrobial resistance. 
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