Katsina

Tuberculosis (TB) is a serious infectious disease causing millions of cases and deaths globally, with a high burden in developing countries like Nigeria. TB mainly affects young adults and is worsened by HIV infection. Current TB treatments are long and challenging, leading to poor compliance and drug resistance. Researchers are studying whether atorvastatin, a cholesterol-lowering drug, can improve TB treatment by making the bacteria more vulnerable and reducing lung damage. Previous Phase II studies showed atorvastatin to be safe and possibly effective, warranting further investigation in this Phase IIC trial. This trial is a multicenter, randomized, open-label study comparing four treatment arms: standard TB drugs alone or combined with daily atorvastatin at doses of 20 mg, 40 mg, or 60 mg for 16 weeks. All participants receive standard anti-TB treatment for 24 weeks. The study will evaluate safety, how quickly the bacteria disappear from sputum, improvements in chest X-rays, and lung function. Participants will be followed closely for 12 months after starting treatment. Participants aged 12 to 65 with confirmed pulmonary TB will have multiple assessments including sputum tests, blood tests, lung function and chest X-rays at various points during and after treatment. Researchers will monitor safety by recording any serious side effects and will measure treatment effectiveness by the time to stable bacterial clearance and disease-free survival at six months. This extended follow-up aims to provide detailed data to support future larger trials.

Researchers are evaluating the pharmacokinetics and pharmacodynamics of atorvastatin at different doses combined with standard first-line treatment for adults with drug-sensitive pulmonary tuberculosis. This sub-study of the ATORTUB trial aims to identify an optimal atorvastatin dosing regimen to support pulmonary tuberculosis treatment. The study is a Phase 2 pharmacokinetics-pharmacodynamics dose-finding trial involving adults aged 12 years and older. Participants will be randomly assigned to one of four groups. All will receive the standard tuberculosis treatment regimen of rifampin, isoniazid, pyrazinamide, and ethambutol for 8 weeks followed by rifampin and isoniazid for 16 weeks. Additionally, three groups will receive daily oral atorvastatin at doses of 20 mg, 40 mg, or 60 mg for the first 16 weeks. The total treatment duration is 24 weeks, followed by a 6-month follow-up period, making total participation last 52 weeks. Throughout the study, participants will attend multiple visits for sputum collection, chest X-rays, lung function tests, and blood sampling to measure pharmacokinetic parameters of atorvastatin and the anti-TB drugs. Blood samples will be taken on day 14 and weeks 8, 16, and 24 after randomization to assess drug concentrations and metabolism. Researchers will monitor safety, treatment adherence, and lung health, with data used to develop a pharmacokinetic/pharmacodynamic model for future dosing recommendations.