Status:
NOT_YET_RECRUITING
A Trial of 2 Disease-Modifying Drugs (Metformin and N-acetylcysteine ) to Promote TB Lung Function Recovery
Lead Sponsor:
Open Source Pharma Foundation
Collaborating Sponsors:
National Institute for Research in Tuberculosis, Chennai, India
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 c...
Detailed Description
Tuberculosis is a leading global cause of morbidity and mortality. Current treatments are inadequate, requiring patients closely adhere to multi-drug regimens that are long, complex, and often poorly ...
Eligibility Criteria
Inclusion
- 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
- 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 %
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2031
Estimated Enrollment :
1104 Patients enrolled
Trial Details
Trial ID
NCT07136987
Start Date
January 1 2026
End Date
July 1 2031
Last Update
August 22 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.