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Airway Injury in TB patients with or without HIV

Airway Injury Risk Mechanisms and IL-6 (AIR-MAIL study) - AIR-MAIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/05/087993
Enrollment
400
Registered
2025-05-30
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere

Interventions

Intervention1: Nil: Nil

Sponsors

National Institutes of Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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 monthsTimepoint: 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

MeasureTime frame
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 patientsTimepoint: Baseline, 2 months and 6 months

Countries

India

Contacts

Public ContactDevasahayam J Christopher

Christian Medical College, Vellore

djchris@cmcvellore.ac.in09443306573

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026