ATORvastatin in Pulmonary TUBerculosis

Summary

Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally. According to recent estimates from the World Health Organization (WHO), over 10 million new cases and 1.6 million deaths from TB occurred in 2021. The vast majority of TB cases and TB deaths are in developing countries. Nigeria has the highest TB burden in Africa with a high number of undetected TB cases as well. The spread of HIV has fueled the TB epidemic, and TB is the leading cause of death among patients infected with HIV and has assumed the lead position as the number one infectious disease cause of death globally. Even though the COVID-19 was associated with a huge mortality, TB contributed significantly to death and one of the single predictors of death among COVID-19 infected individuals. TB predominantly affects young adults in their most productive years of life and has substantial impact on economic development.

Emerging evidence has shown that lipid lowering drugs like statins can make the TB bacteria more susceptible to current treatment regimen. The ATORTUB group recently completed Phase II A and Phase IIB studies to assess the safety, tolerability and efficacy of atorvastatin when administered with the current standard of care. The investigators demonstrated that atorvastatin is well tolerated, save, and has beneficial microbiological and radiological impacts in tuberculosis, thus, warrants further studies.

This phase IIC trial sets out to evaluate the safety and efficacy of different doses of atorvastatin containing regimen, determine rate of decline of viable sputum bacilli, the time to stable sputum conversion, improvement in chest ray severity scores and lung function parameters post randomization in the different treatment arms. The phase II C is a Selection Trial with Extended follow-up STEP and has been devised as a pilot phase III where patients are studied for longer period (12months post randomization) than the usual phase IIB. Thus, providing additional data that will justify a successful phase III trial.

Conditions

• Pulmonary Tuberculosis
• Tuberculosis
• Koch's Disease

Interventions

DRUG

Atorvastatin 20mg

Participants will receive oral atorvastatin 20mg daily for 16 weeks

DRUG

Atorvastatin 40mg

Participants will receive oral atorvastatin 40mg daily for 16 weeks

DRUG

Atorvastatin 60mg

Participants will receive oral atorvastatin 60 mg daily for 16 weeks

DRUG

Fixed dose combination of Rifampicin (R) Isoniazid (H) Pyrazinamide (Z) Ethambutol (E)

Participants will receive 8 weeks of daily oral treatment with rifampin, isoniazid, pyrazinamide, ethambutol, followed by 16 weeks of daily oral treatment with rifampin, isoniazid

Sponsors & Collaborators

• Open Philanthropy

  collaborator OTHER

• Obafemi Awolowo University Teaching Hospital

  lead OTHER

Principal Investigators

• Olanisun O Adewole, MD · Obafemi Awolowo University /Teaching Hospital, Ile- Ife, Osun State, Nigeria

• Olanisun O Adewole, MD · Obafemi Awolowo University/ Teaching Hospital, Ile- Ife, Osun State, Nigeria

• Bolanle A Omotoso, MD · Obafemi Awolowo University/ Teaching Hospital, Ile- Ife, Osun State, Nigeria

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-03

Primary Completion

2026-03-30

Completion

2026-09-30

Countries

• Nigeria

Study Locations