Could a common statin help beat tuberculosis?
NCT ID NCT06199921
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding atorvastatin, a widely used cholesterol-lowering drug, to standard tuberculosis (TB) antibiotics can help clear the infection faster and reduce lung damage. About 440 adults with pulmonary TB will receive either standard treatment alone or with different doses of atorvastatin for 16 weeks. Researchers will track safety, how quickly TB bacteria disappear from sputum, and lung function improvements over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Atorvastatin (a cholesterol-lowering drug) added to standard TB antibiotics
- What this could lead to
- If successful, adding atorvastatin could make TB treatment more effective, helping patients clear the infection faster and with less lung damage.
- What could go wrong
- This is a mid-stage trial, so results are not yet proven. The drug may not improve outcomes or could cause side effects like muscle pain or liver issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 440 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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12 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bowen University Teaching Hospital
RECRUITINGIwo, Osun State, 2345, Nigeria
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Federal Medical Center
RECRUITINGKeffi, Nasarawa State, Nigeria
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Federal Teaching Hospital
RECRUITINGKatsina, Katsina State, Nigeria
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National Tuberculosis Reference Laboratory
RECRUITINGZaria, Kaduna State, Nigeria
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Obafemi Awolowo University Teaching Hospitals Complex
RECRUITINGIle-Ife, Osun State, Nigeria
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University College Hospital
RECRUITINGIbadan, Oyo State, Nigeria
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University of Abuja Teaching Hospital
RECRUITINGGwagwalada, Nigeria
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Usman Danfodio University
RECRUITINGSokoto, Sokoto State, Nigeria
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Other studies related to the condition(s) this trial covers.
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- Can simple sputum and urine tests catch tuberculosis earlier?
- Can a common virus be turned into a TB vaccine? scientists test VIR-1778
- Fish oil meets TB drugs: can Omega-3 help clear infection faster?
- Can starting TB treatment immediately save lives in HIV sepsis?
- A single swab, two diseases: rapid test takes on TB and COVID-19