Clinical trial NCT04721795: Treating Tuberculosis With the Lipid Lowering Drug Atorvastatin in Nigeria(ATORvastatin in Pulmonary TUBerculosis)
Official title: Repurposing a Lipid Lowering Drug to Treat Tuberculosis: Effectiveness of Statins as Adjuvant to Treatment of Pulmonary Tuberculosis in Nigeria
Conditions: Tuberculosis, Pulmonary
Tuberculosis
Summary: Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally, with more than 10 million new cases and over 2 million deaths annually. Developing countries bear the greatest brunt of the disease. The long duration of current treatment is associated with poor compliance, thereby contributing to frequent relapses and to the emergence of drug-resistant TB. In addition, individuals who have been clinically cured may have lung damage, which could be permanent. Therefore, new and more effective therapeutic agents against TB are needed. Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatments. This proof-of-concept clinical trial will add the repurposed drug atorvastatin, commonly used to reduce cholesterol levels, to the standard therapies of TB patients in Nigeria. Atorvastatin is a well-tolerated and safe drug, and its addition is expected to accelerate clearance of the TB-causing bacteria without additional side effects. If this research is successful, it could provide evidence for using a common, easily available generic drug to improve treatment of one of the most debilitating infectious diseases.
Interventions:
description: Participants will receive oral 30/40mg of atorvastatin daily for 2 months together with oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
name: Atorvastatin with standard anti tuberculosis drugs
other_name: Atorvastatin, Statins
type: Drug
description: Participants will receive oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
name: Standard anti tuberculosis drugs only
other_name: Rifampicin, INH, Ethambuthol and Pyrazinamide
type: Drug
Study arms:
design_group_description: Participants will receive oral 30/40mg of atorvastatin daily for 2 months together with oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
design_group_title: Atorvastatin with standard anti tuberculosis drugs
design_group_type: Experimental
design_group_description: Participants will receive oral doses of standard antituberculosis drugs only consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
design_group_title: Anti tuberculosis drugs only
design_group_type: Active Comparator
Sponsor: Obafemi Awolowo University
Collaborators: Cures Within Reach
Drug name mappings:
name: 阿托伐他汀锶
lang: CN
name: Atorvastatin strontium
lang: EN