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CTRI Number  CTRI/2018/12/016579 [Registered on: 10/12/2018] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   Identification of Cell Types and Protein Markers in Tuberculosis patients 
Scientific Title of Study   Quantification of Immune Cell Types and Identification of Cell-Type Specific Biomarker Expression in Pulmonary and Extra-Pulmonary Tuberculosis Patients: a pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Noyal Mariya Joseph 
Designation  Associate Professor 
Affiliation  JIPMER 
Address  Department of Microbiology, JIPMER, Dhanvantri Nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9843094673  
Fax    
Email  noyaljoseph@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Noyal Mariya Joseph 
Designation  Associate Professor 
Affiliation  JIPMER 
Address  Department of Microbiology, JIPMER, Dhanvantri Nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9843094673  
Fax    
Email  noyaljoseph@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Noyal Mariya Joseph 
Designation  Associate Professor 
Affiliation  JIPMER 
Address  Department of Microbiology, JIPMER, Dhanvantri Nagar, Pondicherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9843094673  
Fax    
Email  noyaljoseph@yahoo.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Public Health England 
Address  Public Health England (PHE) Porton, Porton Down, Salisbury, Wiltshire Postcode: SP4 0JG 
Type of Sponsor  Research institution 
 
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 Noyal Mariya Joseph  Jawaharlal Institute of Postgraduate Medical Education and Research  Department of Microbiology, JIPMER, Puducherry -605006
Pondicherry
PONDICHERRY 
9843094673

noyaljoseph@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, JIPMER  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Group 1: All geneXpert positive newly diagnosed treatment naive adult patients (>18 years of age) with pulmonary tuberculosis diagnosed at the Microbiology department
Group 2: All geneXpert positive newly diagnosed treatment naive adult patients (>18 years of age) with extra pulmonary tuberculosis diagnosed at the Microbiology department
Group 3: Bacteriologically confirmed cases of Pneumonia.
Group 4: Healthy volunteers who are negative for Tuberculin Skin Test or Interferon Gamma Release Assay (to rule out latent TB)
 
 
ExclusionCriteria 
Details  HIV positive
Patients on steroids or other immunosuppressive drugs
Pregnant women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will determine immune cell type profiles and specific biomarker expression patterns for various cell-types in PTB and EPTB, as well as in pneumonia (positive lung infection disease control (e.g. H. influenzae and S. pneumoniae) and healthy controls  2 years 
 
Secondary Outcome  
Outcome  TimePoints 
The development of host biomarkers based TB diagnostic kits may help clinicians to screen for, diagnose and follow the progression of TB at an earlier stage  5 years 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2019 
Date of Study Completion (India) 31/07/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/07/2023 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Tuberculosis (TB) presents a serious healthcare crisis. In high burden, low resource countries, poor healthcare access, high cost, and laboratory dependence inhibits testing, leading to delays in diagnosis, increasing transmission and disease severity.  Development of affordable, sensitive and rapid diagnostic tools for diagnosis of TB may play a vital role in resource-poor settings, where the incidence of disease is high. The present study may reveal the expression patterns and/or validity of host biomarkers in whole blood of patients with PTB, EPTB, as well as in healthy controls, which may inform diagnostic test development. Development of host biomarker-based TB diagnostic kits may help clinicians to diagnose and monitor onset and progression of disease at an earlier stage and provide solutions where existing diagnostic options are inadequate. TB diagnostic kits developed from the output of the present study will improve both early diagnosis/triage and patient stratification and will be cost effective and specific. They may be considered an alternative for current diagnostic tests such as IGRA which lack sensitivity and are inadequate and/or expensive.

 
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