Katsina

Tuberculosis TB is a serious infectious disease caused by Mycobacterium tuberculosis, leading to millions of cases and deaths worldwide, particularly in developing countries like Nigeria. TB mainly affects the lungs and is worsened by HIV infection, making it a top cause of death globally. The trial investigates atorvastatin, a cholesterol-lowering drug, to see if it can improve TB treatment by reducing bacteria and lung damage, building on promising earlier studies that showed atorvastatin was safe and may enhance TB therapy outcomes. The trial is a phase IIC, multicenter, randomized, open-label study comparing four treatment groups three different daily doses of atorvastatin 20mg, 40mg, 60mg given for 16 weeks along with standard 6-month anti-TB therapy, and a control group receiving standard therapy alone. Patients are randomly assigned to one of these groups and followed closely for 12 months after starting treatment. The study aims to evaluate safety, the speed at which TB bacteria clear from sputum, improvement in chest X-rays, and lung function. Participants aged 12 to 65 with active pulmonary TB will undergo screening including medical history, HIV and diabetes testing, sputum cultures, blood tests, lung function, and pregnancy tests for women. During the study, sputum samples, blood tests, chest X-rays, and lung function will be monitored regularly. Researchers will track side effects and measure outcomes like TB disease-free survival and symptom improvement at 6 and 12 months. The long follow-up period allows for detailed assessment of treatment effects and safety.

Researchers are studying how atorvastatin, a drug commonly used to lower cholesterol, behaves in the body when combined with the standard first-line treatment for drug-sensitive pulmonary tuberculosis TB in adults. The goal is to understand the drugs pharmacokineticsthe way it is absorbed, distributed, metabolized, and eliminatedand to develop a model that helps find the best dose of atorvastatin to use alongside TB treatment. This study is a phase 2, randomized trial conducted as a sub-study of the larger ATORTUB trial. Participants will be randomly assigned to one of four groups. Three groups will receive standard anti-TB therapy for 24 weeks combined with daily oral atorvastatin at doses of 20 mg, 40 mg, or 60 mg for the first 16 weeks. The fourth group will receive only the standard anti-TB therapy without atorvastatin. The standard TB treatment includes 8 weeks of rifampicin, isoniazid, pyrazinamide, and ethambutol followed by 16 weeks of rifampicin and isoniazid. This parallel dose comparison aims to identify the optimal atorvastatin dose for future TB treatment studies. Participants will attend several study visits over a total of 52 weeks, including 24 weeks of treatment followed by 6 months of follow-up. At each visit, sputum samples, chest X-rays, lung function tests, and blood samples for pharmacokinetic analyses will be collected. Researchers will measure key drug levels such as area under the curve AUC, peak plasma concentration, and plasma clearance for atorvastatin and TB drugs. The study will also evaluate how these drug levels relate to early bactericidal activity, sputum culture conversion, chest X-ray improvement, and lung function changes. Safety and optimal dosing will be assessed throughout the trial.