Parent Study Name: Pulmonary Rehabilitation to Reduce Post-Tuberculosis Morbidity (TB Pure)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohns Hopkins University
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 8 week (short arm) Intervention - pulmonary rehabilitation
- 24 week (long arm) Intervention - pulmonary rehabilitation
Treatment groups
690 Participants
are divided into 3 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
Source ClinicalTrials.gov