| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
|
|
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. |