Status:
RECRUITING
ATORvastatin in Pulmonary TUBerculosis
Lead Sponsor:
Obafemi Awolowo University Teaching Hospital
Collaborating Sponsors:
Open Philanthropy
Conditions:
Pulmonary Tuberculosis
Tuberculosis
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief 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 mil...
Detailed Description
INTRODUCTION Tuberculosis is a chronic disease responsible for most deaths from infectious disease with an estimated I0 million cases and close to 2 million deaths globally. Despite the availability o...
Eligibility Criteria
Inclusion
- 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 individuals, CD4 T cell count greater than or equal to 100 cells/mm3 based on testing performed at or within 30 days prior to screening.
- H. Laboratory parameters done at or within 14 days prior to screening:
- Serum or plasma alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal
- Serum or plasma total bilirubin less than or equal to 2.5 times the upper limit of normal
- Serum or plasma creatinine level less than or equal to 2 times the upper limit of normal
- Serum or plasma potassium level greater than or equal to 3.5 meq/L
- Hemoglobin level of 7.0 g/dL or greater
- Platelet count of 100,000/mm3 or greater
- I. For women of childbearing potential, a negative pregnancy test at or within seven (7) days prior to screening
- J. Written informed consent
Exclusion
- Individuals with any of the following exclusion criteria at the time of enrollment or initiation of study drugs will be excluded.
- A. Pregnant or breast-feeding
- B. Unable to take oral medications
- C. Those already on treatment for tuberculosis
- D. Weight less than 40.0 kg
- E. Known allergy or intolerance to any of the study medications
- F. Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide,or ethambutol,
- G. .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.
- H. Known or family history of bleeding disorders. I. Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.
- J. Myositis and or Creatinine phosphokinase three times upper limit of normal K. Other medical conditions, that, in the investigator's judgment, make study participation not in the individual's best interest.
- Criteria for Exclusion after Enrollment ('Late Exclusion')
- Microbiological confirmation of drug-susceptible tuberculosis is not expected always to be available at the time of enrollment. Enrolled individuals who are subsequently determined to meet either of the following criteria will be classified as 'late exclusions' and study treatment will be discontinued:
- A. Screening, baseline, and Week 2 study visit sputum cultures all fail to grow M. tuberculosis.
- B. M. tuberculosis cultured or detected through molecular assays (Cepheid Xpert MTB/RIF or Hain MTBDRplus assays) from sputum obtained around the time of study entry is determined to be resistant to one or more of isoniazid, rifampin, or fluoroquinolones.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT06199921
Start Date
January 3 2024
End Date
September 30 2026
Last Update
September 25 2025
Active Locations (8)
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1
National Tuberculosis Reference Laboratory
Zaria, Kaduna State, Nigeria
2
Federal Teaching Hospital
Katsina, Katsina State, Nigeria
3
Federal Medical Center
Keffi, Nasarawa State, Nigeria
4
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, Nigeria