Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Jul 7, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for pulmonary tuberculosis (TB) that uses a combination of medications called sitafloxacin, isoniazid, rifapentine, and pyrazinamide. The goal is to see if a shorter three-month treatment can be just as effective and safe as the current standard treatments, which last either six months or four months. Participants will be divided into different groups to compare how well the new three-month regimen works against the standard treatments and to monitor any side effects from the medications.

To be eligible for the trial, participants must be between 18 and 70 years old and have a confirmed TB infection that is sensitive to the study drugs. This means that their TB bacteria can be treated effectively with the medications being studied. They must also provide written consent to participate. However, those with certain health conditions, such as HIV, severe liver or kidney problems, or who are pregnant or breastfeeding, will not be able to join. Participants can expect to receive close monitoring during the study, including checking for how well the treatment is working and any potential side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years to 70.
• • 2. At least one sputum specimen is positive for acid-fast bacilli or positive results of sputum culture on smear microscopy(species identification as M. tuberculosis) or at least one sputum specimen positive for M. tuberculosis by Xpert MTB/RIF testing.
• • 3. Phenotypic drug susceptibility testing indicates the patient's isolate is susceptible to rifampin, isoniazid, pyrazinamide, ethambutol, rifapentine, moxifloxacin, and Sitafloxacin.
• • 4. Patients have written informed consent.
• Exclusion Criteria:
• • 1. Extra-pulmonary or Disseminated TB.
• • 2. HIV-positive individuals, steroid-dependent and those on steroid treatment.
• • 3. Autoimmune diseases, severe hepatic or renal dysfunction, psychosis, hematological malignancies, cancer, diabetes individuals.
• • 4. Known allergy to one or more of the study drugs.
• • 5. Women who are currently pregnant or breast-feeding.
• • 6. Patients who received any investigational drug in the past three months.
• • 7. The patients refused treatment with medications
• • 8. Mycobacterium tuberculosis/nontuberculous mycobacterium co-infection.
• • 9. In the investigator's judgment, other medical conditions that are not in the individual's best interest to participate.