| CTRI Number |
CTRI/2025/05/087993 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Airway Injury in TB patients with or without HIV |
|
Scientific Title of Study
|
Airway Injury Risk Mechanisms and IL-6 (AIR-MAIL study) |
| Trial Acronym |
AIR-MAIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devasahayam J Christopher |
| Designation |
Sr. Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Pulmonary Medicine
Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU
632517
India |
| Phone |
09443306573 |
| Fax |
|
| Email |
djchris@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Devasahayam J Christopher |
| Designation |
Sr. Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Pulmonary Medicine
Christian Medical College, Vellore (Ranipet Campus)
TAMIL NADU
632517
India |
| Phone |
09443306573 |
| Fax |
|
| Email |
djchris@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Devasahayam J Christopher |
| Designation |
Sr. Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Pulmonary Medicine
Christian Medical College, Vellore (Ranipet Campus)
TAMIL NADU
632517
India |
| Phone |
09443306573 |
| Fax |
|
| Email |
djchris@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland, Zip Code: 20892, United States of America |
|
|
Primary Sponsor
|
| Name |
National Institutes of Health |
| Address |
9000 Rockville Pike, Bethesda Maryland 20892 USA |
| Type of Sponsor |
Other [US Funding agency] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sanjay Gaikwad |
Byramjee Jeejeebhoy Government Medical College |
GVC8+Q6P JPN Road Railway Station Rd
Pune 411001 India
Pune
MAHARASHTRA |
9890423689
sangaiabdc@gmail.com |
| Dr DJ Christopher |
Christian Medical College |
Department of Pulmonary Medicine, A201,
Christian Medical College, Vellore (Ranipet Campus)
Vellore
TAMIL NADU |
09443306573
djchris@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee- BJ Medical College and Sassoon General Hospitals |
Approved |
| Institutional Review Board, Office of Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Clinically (symptoms and/or chest X-ray) or microbiologically (sputum smear microscopy, GeneXpert or culture) confirmed pulmonary TB disease
Has already or is planning to initiate TB treatment
Laboratory confirmed HIV-positive status
Currently receiving ART for at least 6 months
Ability and willingness to provide informed consent.
|
|
| ExclusionCriteria |
| Details |
Extra-pulmonary TB case without pulmonary disease on clinical (symptoms and/or chest X-ray) or microbiological (sputum smear microscopy, GeneXpert or culture) assessment
TB case with multi- or extensively-drug resistant TB
Prior TB regardless of treatment duration
Received TB treatment for over 7 days for current TB episode
History of any chronic lung disease including COPD and asthma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the proportion of participants with any phenotype of lung function impairment - airflow obstruction, restriction or mixed ventilatory defect - between HIV-positive and HIV-negative TB patients at 6 months |
Compare the proportion of participants with any phenotype of lung function impairment - airflow obstruction, restriction or mixed ventilatory defect - between HIV-positive and HIV-negative TB patients at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the proportion of participants with persistent PTLD i.e., airflow obstruction, restriction or mixed ventilatory defect at 6 and 12 months, between HIV-positive and HIV-negative TB patients |
Baseline, 2 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
03/08/2025 |
| 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="5"
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 overarching goal of this proposal is to compare the burden, severity, and phenotypic presentation of post TB lung disease (PTLD), and its association with IL-6 signaling pathways, in TB patients with and without HIV. We will leverage the ongoing NIH-funded RePORT-India TB Research Consortium, a multi-site study that is already evaluating over 200 HIV-negative adults with drug-sensitive TB for longitudinal lung health assessments during and after TB treatment, along with whole blood and induced sputum biobanking for immunological testing. Through this R01 application, we propose enrolling a comparison cohort of 200 consecutive HIV-positive drug-sensitive TB patients receiving anti-retroviral therapy (ART), who will follow identical study protocols. | | Category I* | Category II* | Category III* | Category IV* | | Author(s) name | Research and Study design | Data collection & Analysis | Laboratory analysis | Interpretation and conclusion | Preparation of Manuscript | Review of Manuscript | Guide and critical revision | Final approval of the version to be published | Agreement to be accountable for all aspects of the research work | | DJ Christopher | √ | | | √ | √ | √ | √ | √ | √ | | Akshay Gupta | √ | | | √ | √ | √ | √ | √ | √ | | Balamugesh Thangakunam | √ | | | √ | √ | √ | √ | √ | √ | | Dr. Sanjay Gaikwad | √ | | | √ | √ | √ | √ | √ | √ | | Dr. Amita Gupta | √ | | | √ | √ | √ | √ | √ | √ |
|