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New treatment option for Tuberculosis (TB)
Official title A Confirmatory Trial of Adjunctive NAC to Prevent Post Tuberculosis Lung Disease
ClinicalTrials.gov ID: NCT06909799
What this study is testing
What is N-Acetyl Cysteine (NAC)?
N-Acetyl Cysteine (NAC) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for tuberculosis (tb).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate if N-acetylcysteine (NAC) works to prevent post-tuberculosis lung disease (PTLD) in patients with severe pulmonary impairment. It also aims to assess the safety of NAC.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Persons aged 18 to 65 years
- Willing and able to provide signed written consent, or witnessed oral con-sent with thumbprint in the case of illiteracy, prior to undertaking any...
- Body weight (in light clothing without shoes) between 30 and 90 kg.
- Xpert TB/RIF OR Ultra showing RIF-S-MTB, with subsequent confirmation of MTB by culture.
- Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis 1
You likely can't join if
- Any condition for which participation in the trial, as judged by the investigator, could compromise the well-being of the subject or prevent, limit...
- Pregnancy or breast-feeding
- 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 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, including known allergy or suspected hypersensitivity to...
- Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an...
See the full eligibility criteria
- Persons aged 18 to 65 years
- Willing and able to provide signed written consent, or witnessed oral con-sent with thumbprint in the case of illiteracy, prior to undertaking any trial-related procedures.
- Body weight (in light clothing without shoes) between 30 and 90 kg.
- Xpert TB/RIF OR Ultra showing RIF-S-MTB, with subsequent confirmation of MTB by culture.
- Chest radiograph meeting criteria for moderate or far advanced pulmonary tuberculosis 1
- FEV1 ≤65% of predicted adjusted for age, height, sex, and race
- If female, of child-bearing potential and sexually active, willing to use a contraceptive method for the duration of study participation
- HIV-1/2 seronegative, or if seropositive: CD4 T cell count ≥100/mcL and either currently receiving ART or willing to start ART during study participation
- 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, such as pneumothorax or...
- Pregnancy or breast-feeding
- 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 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, including known allergy or suspected hypersensitivity to rifampin.
- Having participated in other clinical trials with investigational agents within 8 weeks prior to trial start or currently enrolled in an investigational trial.
- No more than 5 days treatment for the current TB episode, and no other TB treatment in the preceding 6 months
- 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
- Random blood glucose \>140 mg/dL (or \>7.8 mmol/L), or history of unstable Diabetes Mellitus which required hospitalization for hyper- or hypoglycaemia within the past year prior to start of screening.
- Use of systemic corticosteroids within the past 28 days, or a likely to require corticosteroids for management of another medical condition during the period of study participation.
- Patients requiring treatment with medications not compatible with rifampin, such as HIV protease inhibitors
- people with any of the following abnormal laboratory values:
- creatinine \>2 mg/dL
- haemoglobin \<8 g/dL
- platelets \<100x109 cells/L
- serum potassium \<3.5
- aspartate aminotransferase (AST) ≥2.0 x ULN
- alkaline phosphatase (AP) \>5.0 x ULN
- total bilirubin \>1.5 mg/dL
- positive HBsAg
The study team makes the final eligibility decision.
Where it's taking place
- Fajara, The Gambia, The Gambia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fajara, The Gambia, The Gambia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.