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

Launched by HUASHAN HOSPITAL · Oct 17, 2024

Keywords

ClinConnect Summary

This clinical trial, called the BDLL Chinese Cohort, is investigating a new 6-month treatment for rifampin-resistant pulmonary tuberculosis (RR-TB) in teenagers and adults in China. The treatment includes a combination of oral medications: Bedaquiline, Delamanid, Linezolid, Levofloxacin, or Clofazimine. The main goals of the study are to see if this new treatment is effective in fighting RR-TB and to determine if it is safe for patients. Participants will not need extra hospital visits or tests outside of their regular care.

To be eligible for this trial, participants should be at least 12 years old, weigh 30 kg or more, and have a confirmed diagnosis of RR-TB. They also need to agree to follow the trial procedures and provide consent. Additionally, women should not be pregnant or breastfeeding, and both men and women must use effective birth control during the study. Participants can expect to take the oral medications for six months and will be monitored regularly for their health throughout the trial. This study aims to provide a potentially simpler and more effective treatment option for those suffering from drug-resistant tuberculosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants are willing to sign informed consent of this trial, those without capacity for civil conduct need their legal guardian to sign
• • Participants (and their legal guardian if applicable) are willing to cooperate to complete all trial procedures
• • Male or female, 12 years or older, weight ≥ 30kg
• • Confirmed pulmonary tuberculosis with resistance to rifampin by phenotypic or genotypic susceptibility testing within 3 months, and must be re-confirmed by sputum culture sampled at trial inclusion
• • Women with childbearing potential should not be pregnant, confirmed by a volunteered negative pregnancy test, and are willing to use effective contraceptive method from giving consent to 3 months after study treatment
• • Men with childbearing potential must be willing to use condom or other effective contraceptive methods to avoid their sex partners from being pregnant
• • Women in breastfeeding period must be willing to discontinue breastfeeding from giving consent to 3 months after study treatment
• • Participants are willing to take HIV test, and willing to take appropriate antiretroviral therapy if positive
• Exclusion Criteria:
• • Previously use of Bedaquiline or Delamanid for at least 28 days
• • Concomitant hematogenous disseminated tuberculosis, or severe pulmonary tuberculosis in investigator's opinion (including tuberculosis of the digestive system, osteoarticular tuberculosis or tuberculous meningitis)
• • Currently using any drug that has been prohibited in the protocol
• • History of allergic action to any of the study drugs
• • Currently participating in any other clinical trials
• • Cardiovascular risk at screening: (1) QTcF more than 480 milliseconds (ms); (2) History of clinically significant arrythmia, and at investigator's opinion, participation in this study will increase the risk; (3) Decompensated heart failure; (4) Grade 3 high blood pressure and the goals of treatment have not been reached; (5) Abnormal thyroid function; (6) Abnormal serum Ca, Mg or K level; (7) Other conditions with cardiovascular risks in investigator's opinion.
• • History of optic neuropathy or peripheral neuropathy, and the investigator considers that the condition may progress or deteriorate by participating in the study, or inappropriate to participate
• • Hepatic disorders at screening: (1) Active viral hepatitis: HBsAg positive or HBV DNA \>1000 CPs/mL, with elevated AST or ALT or HCV RNA positive; (2) Decompensated cirrhosis
• • Renal disorders at screening: (1) Unstable or rapidly progressive renal disease; (2) Moderate / severe renal disfunction or end-stage renal disease (eGFR\< 60 mL/min/1.73 m2); (3) Serum creatinine ≥133 μmol/L(1.5 mg/mL) in men, or ≥124 μmol/L (1.4 mg/mL) in women
• • Other abnormal laboratory test: (1) Hemoglobin \< 8.0g/dL; (2) Platelet \<75,000/mm3; (3) Absolute neutrophil count \<1000/mm3; (4) Aspartate transaminase (AST) or alanine aminotransferase (ALT) \>3×upper limit of normal (ULN); (5) Total bilirubin (TBil) \>2×ULN, or \>1.5×ULN together with abnormal AST or ALT; (6) Albumin \<30g/L
• • The investigator considers that the participant is not able to complete the study process, or the participation is not safe.