NCT07164742 Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
| NCT ID | NCT07164742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Johns Hopkins University |
| Condition | TB - Tuberculosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 690 participants |
| Start Date | 2026-03-18 |
| Primary Completion | 2028-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 690 participants in total. It began in 2026-03-18 with a primary completion date of 2028-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Individual-level, unblinded randomized controlled trial of an 8-week (short arm) or 24-week (extended arm) pulmonary rehabilitation program, relative to standard of care, to prevent post-tuberculosis respiratory morbidity. Randomization will occur in a 1:1:1 ratio at the initiation of treatment.
Eligibility Criteria
Inclusion Criteria: * Age at least 18 years * Microbiologically confirmed (smear microscopy, GeneXpert or culture) pulmonary TB disease\* * Not completed more than 2 weeks of TB treatment * Receiving TB care at the outpatient clinics at the TB PuRe study sites * Willingness to complete 48 weeks of study evaluations. * Access to a smartphone. Exclusion Criteria: * Modified Medical Research Council score of 0 points (dyspnea only with strenuous exercise) * Multi or extensively drug-resistant TB disease\* * Extrapulmonary TB disease at any clinical sites without pulmonary involvement * TB meningitis or TB of the spine * Symptomatic cardiovascular disease, including coronary artery disease, arrhythmias and congestive cardiac failure. * Karnofsky Score \< 40 points * Any medical condition that prevents pulmonary rehabilitation eg: fracture of lower/upper limbs/pregnancy * Bronchodilators and/or corticosteroids inhaled or otherwise.
Contact & Investigator
Akshay Gupte, PhD MBBS MSPH
PRINCIPAL INVESTIGATOR
Boston University
Frequently Asked Questions
Who can join the NCT07164742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying TB - Tuberculosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07164742 currently recruiting?
Yes, NCT07164742 is actively recruiting participants. Contact the research team at agupte1@bu.edu for enrollment information.
Where is the NCT07164742 trial being conducted?
This trial is being conducted at Mangalore, India, Pune, India.
Who is sponsoring the NCT07164742 clinical trial?
NCT07164742 is sponsored by Johns Hopkins University. The principal investigator is Akshay Gupte, PhD MBBS MSPH at Boston University. The trial plans to enroll 690 participants.