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New treatment option for Pulmonary Tuberculosis (TB)
Official title ATORvastatin in Pulmonary TUBerculosis: a POPulation PharmacoKinetics -PharmacoDynamics Sub-study (ATORTUB popPK-PD)
ClinicalTrials.gov ID: NCT07303699
What this study is testing
What is Atorvastatin 20 mg?
Atorvastatin 20 mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pulmonary tuberculosis (tb).
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
- The purpose of this study is to assess pharmacokinetic parameters of atorvastatin at different doses when combined with the standard first line tuberculosis (TB) treatment regimen in adults with drug sensitive pulmonary TB. The pharmacokinetics parameters will be correlated with Pharmcodynamic measures and a PK/PD model that will identify an optimal dosing regimen of atorvastatin that is appropriate for the treatment of pulmonary tuberculosis will be developed.
- 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 and older
You may be able to join if
- Sputum specimen positive for tubercle bacilli on Gene Xpert or direct smear microscopy
- Either no previous anti-TB chemotherapy, or less than 2 weeks of previous chemotherapy
- Aged 12years and above
- A firm home address that is readily accessible for visiting
- Agreement to participate in the study and to give a sample of blood for HIV testing
You likely can't join if
- Participants known or suspected of having any form of drug resistance TB.
- Patients co infected with HIV
- Those with poor general condition where no delay in treatment can be tolerated
- Evidence of clinically significant metabolic or co morbid medical conditions ; malignancy; or other diseases like history of or current...
- Known or family history of bleeding disorders.
- Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at...
See the full eligibility criteria
- Sputum specimen positive for tubercle bacilli on Gene Xpert or direct smear microscopy
- Either no previous anti-TB chemotherapy, or less than 2 weeks of previous chemotherapy
- Aged 12years and above
- A firm home address that is readily accessible for visiting
- Agreement to participate in the study and to give a sample of blood for HIV testing
- Normal baseline laboratory values 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
- Informed consent to participate in the study and to give a sample of blood for HIV testing
- Participants known or suspected of having any form of drug resistance TB.
- Patients co infected with HIV
- Those with poor general condition where no delay in treatment can be tolerated
- 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.
- Known or family history of bleeding disorders.
- Any renal impairment characterized by serum creatinine clearance of 1.5 x upper limit of normal of the clinical laboratory reference range at screening.
- Myositis and or Creatinine phosphokinase three times upper limit of normal
- Patient in a moribund state
- Has TB meningitis
- Presence of any of the pre-existing non-TB diseases outlined in the protocol
- Diabetes mellitus
- Hypertension
- Currently on anti TB medication
- Any other chronic illness/ co morbidities that warrants being on daily routine medications
- Presence of a psychiatric illness
- pregnant, or breast feeding mothers
- Current Tobacco Smokers/ tobacco use in any form
- Alcoholism
- alcoholic beverages, food or drinks containing methyl- xanthine (i.e. energy drinks, tea leaves, coffee beans, cocoa, kola nuts, medications e.g. theophylline). Ingestion of grapefruit/ products containing grapefruit...
- Individuals that are enrolled in other therapeutic clinical trials
The study team makes the final eligibility decision.
Where it's taking place
- Zaria, Kaduna State, Nigeria
- Katsina, Katsina State, Nigeria
- Ile-Ife, Osun State, 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 and older. 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; Ile-Ife, Osun State, Nigeria. 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.