ATORvastatin in Pulmonary TUBerculosis

Launched by OBAFEMI AWOLOWO UNIVERSITY TEACHING HOSPITAL · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial, called ATORvastatin in Pulmonary Tuberculosis, is exploring whether a medication called atorvastatin, which is usually used to lower cholesterol, can also help people with tuberculosis (TB). TB is a serious infectious disease that affects millions of people worldwide, especially in countries like Nigeria. The researchers want to see if adding atorvastatin to the standard TB treatment can make the TB bacteria easier to kill and improve recovery. They are testing different doses of atorvastatin to find out how safe it is and how effective it can be in helping patients recover from TB.

To participate in this trial, individuals must be at least 12 years old and have suspected pulmonary tuberculosis confirmed by specific tests. They must not have previously received TB treatment and should have a stable health status, including certain acceptable blood test results. Participants can expect to receive regular check-ups and monitoring over a 12-month period, which will help the researchers gather important information about the treatment's safety and effectiveness. It's essential for potential participants to understand that if they have specific health conditions or are currently pregnant, they may not be eligible for the study.

Gender

ALL

Eligibility criteria

• 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.