Treating Tuberculosis With the Lipid Lowering Drug Atorvastatin in Nigeria(ATORvastatin in Pulmonary TUBerculosis)

• Status: Recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Obafemi Awolowo University Teaching Hospital
• Collaborators: Birmingham Heartlands Hospital; Cures Within Reach; Cures Within Reach, USA; University Hospital Birmingham NHS Foundation Trust
• Treatments: Antitubercular Agents; Atorvastatin

Criteria

Inclusion Criteria:

• Inclusion Criteria:

1. Newly diagnosed, uncomplicated, drug-susceptible pulmonary TB

2. Sputum Smear, culture or GenXpert result positive for pulmonary TB

3. Ability to provide written, informed consent prior to trial initiation

4. Male or and non pregnant female participants between 18 and 65 years of age

5. Body mass index 16.0 and 32.0 kg/m2

6. Ability to produce an adequate volume of sputum (approximately 10 -15mL or more estimated overnight production).

Exclusion Criteria:

Exclusion Criteria:

1. Participants known or suspected of having any form of drug resistance TB.

2. Patients co infected with HIV

3. Those with poor general condition where no delay in treatment can be tolerated

4. Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current cardiovascular disorder such as heart failure, coronary heart disease, arrhythmia.

5. Known or family history of bleeding disorders.

6. Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.

7. Myositis and or Creatinine phosphokinase three times upper limit of normal