Innovating Shorter, All- Oral, Precised Treatment Regimen for Rifampicin Resistant Tuberculosis：BLMZ Chinese Cohort

Korábbi kezelés

• Previous treatment with any of the drugs Bedaquiline (BDQ) or Linezolid (LZD) for more than 30 days.
• Concurrent hematogenous disseminated pulmonary tuberculosis or severe extrapulmonary tuberculosis as determined by the investigator.
• Current use of medications prohibited by the study protocol, and the investigator judges that the priority of continuing said medication for patient benefit outweighs participation in this study.
  • （Note: If the investigator judges that the benefit of participating in this study is higher and obtains the participant's consent, the prohibited medication should be discontinued with an adequate washout period before participation.）
• Current participation in any other investigational drug clinical trial.

Más betegség

• Known history of hypersensitivity to any drug in the protocol.
• History of optic neuropathy or peripheral neuropathy, which in the investigator's opinion may progress/worsen during the study or is unsuitable for study participation.
• Any other condition (e.g., severe psychiatric disorder, neurological condition, substance abuse) that, in the opinion of the investigator, would make the participant unsuitable for the study or unable to adhere to the protocol.

Laborértékek

• Presence of cardiovascular disease risk at screening:
  • QTcF interval >450 milliseconds (ms). (Note: If QTcF >450 ms is detected, one unscheduled visit during the screening period is allowed for re-assessment.)
  • History of clinically significant arrhythmia within 60 days prior to enrollment, which in the investigator's opinion may increase risk upon study participation.
  • Decompensated heart failure.
  • Grade 3 hypertension not at control target.
  • Abnormal thyroid function.
  • Abnormal serum calcium, magnesium, or potassium levels. (Note: Isolated electrolyte disturbances without underlying disease may be considered for re-screening after corrective treatment.)
  • Other conditions deemed by the investigator to pose a cardiovascular disease risk.
• Evidence of liver disease at screening:
  • Active viral hepatitis: Positive HBsAg, or positive HBeAg and HBV DNA, or positive HCV RNA test, accompanied by persistent or recurrent abnormal ALT.
  • Decompensated cirrhosis.
• History of renal disease or renal disease-related manifestations at screening:
  • History of unstable or rapidly progressive renal disease.
  • Moderate/severe renal impairment or end-stage renal disease (eGFR < 60 mL/min/1.73 m²).
  • Serum creatinine (Cr) ≥133 μmol/L (1.5 mg/dL) for males, or Cr ≥124 μmol/L (1.4 mg/dL) for females.
• Other laboratory abnormalities at screening:
  • Hemoglobin level < 8.0 g/dL.
  • Platelet count <75,000 /mm³.
  • Absolute neutrophil count (ANC) <1000 /mm³.
  • Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN).
  • Total bilirubin >2 times ULN, or >1.5 times ULN accompanied by other abnormal liver enzymes.
  • Albumin <30 g/L.

Egyéb

• Pregnant or breastfeeding.

• The participant (and their guardian if the participant lacks civil capacity) voluntarily signs the informed consent form (ICF) prior to enrollment.
• The participant (and their guardian) indicates willingness to complete all steps and intervention periods of the study.
• Male or female, aged ≥12 years, with a body weight ≥30 kilograms (kg).
• Bacteriologically confirmed pulmonary tuberculosis, with molecular or phenotypic drug susceptibility testing (DST) results within the last 3 months confirming Rifampicin resistance and susceptibility to at least one of Moxifloxacin (MFX) or Levofloxacin (LFX).
• Sputum or respiratory lavage fluid collected during the screening period is culture-positive for Mycobacterium tuberculosis, with DST results indicating Rifampicin resistance and susceptibility to at least one of MFX or LFX.
• Females of childbearing potential are not pregnant (as confirmed by a negative pregnancy test), voluntarily agree to pregnancy testing, and are willing to use highly effective contraception from the time of ICF signing until 3 months after the end of study treatment.
• For males of reproductive potential, use condoms or other methods to ensure effective contraception for their partner.
• Females who are breastfeeding are willing to discontinue breastfeeding from the time of ICF signing until 3 months after the end of study treatment.
• Voluntary acceptance of HIV testing; if the result is positive, voluntary acceptance of antiretroviral therapy.