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New treatment option for Pulmonary Tuberculosis
Official title ATORvastatin in Pulmonary TUBerculosis
ClinicalTrials.gov ID: NCT06199921
What this study is testing
What is Atorvastatin 20mg?
Atorvastatin 20mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pulmonary tuberculosis.
Also referred to as Astin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Tuberculosis (TB) is caused by mycobacterial organism. It is the leading infectious disease cause of death globally.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Individuals must meet all the following in order to participate in this study: A. Suspected pulmonary tuberculosis plus one or both of the following...
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Individuals must meet all the following 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...
- 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
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- 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
- Sokoto, Sokoto State, Nigeria
- Gwagwalada, Nigeria
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.