ATORvastatin in Pulmonary TUBerculosis
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 devel
| Condition(s) | Pulmonary Tuberculosis, Tuberculosis, Koch's Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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-1 |
| Who can participate | Inclusion Criteria: Individuals must meet all the following inclusion criteria in order to participate in this study: A. Suspected pulmonary tuberculosis plus one or both of the following: a) at least one sputum specimen positive for acid-fast bacilli on smear microscopy OR b) at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing, with semiquantitative result of 'medium' or 'high' and rifampicin resistance not detected. B. Treatment naive C. Age twelve years or older D. A verifiable address or residence location that is readily accessible for visiting, and willingness to inform the study team of any change of address during the treatment and follow-up period. E. Documented HIV infection status. F. Documented blood sugar level/ Diabetes G. For HIV-positive indiv |
| Ages | 12 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Obafemi Awolowo University Teaching Hospital |
| Locations | Zaria, Kaduna State, Nigeria; Katsina, Katsina State, Nigeria; Keffi, Nasarawa State, Nigeria; Ile-Ife, Osun State, Nigeria; Iwo, Osun State, Nigeria; Ibadan, Oyo State, Nigeria (+2 more sites) |
| Start date | 2024-01-03 |
| NCT ID | NCT06199921 |
| Official listing | https://clinicaltrials.gov/study/NCT06199921 |