A Trial of 2 Disease-Modifying Drugs (Metformin and N-acetylcysteine ) to Promote TB Lung Function Recovery

Launched by OPEN SOURCE PHARMA FOUNDATION · Aug 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether two medicines, metformin and N-acetylcysteine (NAC), can help improve lung healing in people being treated for tuberculosis (TB). TB is an infection that mainly affects the lungs and can cause long-term damage even after the infection is cured. These two drugs are being tested alongside the usual TB treatment to see if they can help the lungs recover better and prevent lasting problems with breathing. Right now, no medicines are officially approved for this purpose.

People who might be eligible to join are adults with confirmed lung TB who have some loss of lung function, measured by breathing tests, and who are ready to start the standard six-month TB treatment. To join, participants need to be between 18 and 74 years old, weigh between 30 and 90 kg, and meet certain health criteria like not being pregnant and having no serious other illnesses. Participants will be closely monitored throughout the study to check their lung health and overall well-being. It’s important to know that this trial is not yet recruiting, but if you or a loved one fits these criteria and is interested, it’s a good idea to speak with a healthcare provider for more information.

Gender

ALL

Eligibility criteria

• 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 meningitis or spondylitis, or other forms of severe tuberculosis with high risk of a poor outcome as judged by the investigator.
• • History of allergy or hypersensitivity to any of the trial therapies or related substances.
• • History of a chronic lung condition (including COPD or asthma) requiring treatment in the previous year
• • Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.
• • Prior TB treatment in the preceding 6 months, other than within the 7 days immediately prior to enrollment.
• • Angina pectoris requiring treatment with nitroglycerin or other nitrates
• • Cardiac arrhythmia requiring medication, or any clinically significant ECG abnormality, in the opinion of the investigator
• • History of diabetes mellitus requiring treatment with metformin or resulting in hospitalization for hyper- or hypoglycaemia within the past year prior to start of screening
• • Use of systemic corticosteroids within the past 28 days.
• • Patients requiring treatment with medications not compatible with rifampin, such as HIV-1 protease inhibitors
• • History of Pneumoconiosis.
• • Subjects with any of the following abnormal laboratory values: hemoglobin \<8 g/dL, platelets \<100x109 cells/L, serum potassium \<3.5 mM/L, alanine aminotransferase (ALT) ≥2.0 x ULN, alkaline phosphatase (AP) \>5.0 x ULN, total bilirubin \>1.5 mg/dL, HbA1c \>6.5 %