A Trial of 2 Disease-Modifying Drugs (Metformin and N-acetylcysteine ) to Promote TB Lung Functio… (NCT07136987) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Trial of 2 Disease-Modifying Drugs (Metformin and N-acetylcysteine ) to Promote TB Lung Function Recovery
1,104 participantsStarted 2026-01
Plain-language summary
Tuberculosis is a leading global cause of morbidity and mortality. Even if cured, a majority patients are left with bronchiectasis and fibrosis, permanent conditions that impair lung function. Large cohort studies have confirmed that even modest loss of lung function is associated with excess mortality risk. This study will examine if two treatments, metformin and N-acetylcysteine (NAC), can promote the recovery of lung function in TB if given together with standard TB treatment. There currently are no drugs approved for this indication.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Willing and able to provide signed written consent (or, in the case of illiteracy, witnessed oral consent plus patient thumbprint) prior to undertaking any trial-related procedures.
* Body weight (in light clothing without shoes) between 30 and 90 kg.
* Radiographic evidence of pulmonary tuberculosis
* Positive Xpert TB/RIF (original or Ultra) for MTB
* RIF susceptibility diagnosed by Xpert TB/RIF, with subsequent culture confirmation
* FEV1≤65% of predicted
* Eligible for treatment with a 6-month regimen comprised of INH, RIF, EMB, and PZA
* If sexually active, willing to use effective contraceptive methods for a period of 9 months (3 months post-study treatment)
* HIV-1 seronegative, or if HIV-1 seropositive, presenting to a non-India clinical site with a CD4 T cell count ≥100/µl and either receiving ART or willing to start ART during study participation
* SARS-CoV-2 PCR or antigen test negative, or if positive, either fully vaccinated against Covid-19 or with D-dimer \<1 µg/ml
* eGFR ≥30 ml/min/1.73 m2 (CKD EPI 2009)
Exclusion Criteria:
* Any condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments
* Currently pregnant or nursing, or pregnancy planned in next 12 months
* Is critically ill, and in the judgment of the investigator has a diagnosis likely to result in death during the trial or the follow-up period.
* TB meni…