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Could a common statin help beat tuberculosis?

NCT ID NCT06199921

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 440 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

12 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Bowen University Teaching Hospital

    RECRUITING

    Iwo, Osun State, 2345, Nigeria

  • Federal Medical Center

    RECRUITING

    Keffi, Nasarawa State, Nigeria

  • Federal Teaching Hospital

    RECRUITING

    Katsina, Katsina State, Nigeria

  • National Tuberculosis Reference Laboratory

    RECRUITING

    Zaria, Kaduna State, Nigeria

  • Obafemi Awolowo University Teaching Hospitals Complex

    RECRUITING

    Ile-Ife, Osun State, Nigeria

  • University College Hospital

    RECRUITING

    Ibadan, Oyo State, Nigeria

  • University of Abuja Teaching Hospital

    RECRUITING

    Gwagwalada, Nigeria

  • Usman Danfodio University

    RECRUITING

    Sokoto, Sokoto State, Nigeria

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