Rifapin-resistant Pulmonary tuberculosis
Conditions
Interventions
Treatment Group:BDLLfxC Regimen
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
12 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.Participants are willing to sign informed consent of this trial, those without capacity for civil conduct need their legal guardian to sign; 2.Participants (and their legal guardian if applicable) are willing to cooperate to complete all trial procedures; 3.Male or female, 12 years or older, weight >= 30kg; 4.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; 5.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; 6.Men with childbearing potential must be willing to use condom or other effective contraceptive methods to avoid their sex partners from being pregnant; 7.Women in breastfeeding period must be willing to discontinue breastfeeding from giving consent to 3 months after study treatment; 8.Participants are willing to take HIV test, and willing to take appropriate antiretroviral therapy if positive;
Exclusion criteria
Exclusion criteria: 1.Previously use of Bedaquiline or Delamanid for at least 28 days; 2.Concomitant hematogenous disseminated tuberculosis, or severe pulmonary tuberculosis in investigator’s opinion (including tuberculosis of the digestive system, osteoarticular tuberculosis or tuberculous meningitis); 3.Currently using any drug that has been prohibited in the protocol; 4.History of allergic action to any of the study drugs; 5.Currently participating in any other clinical trials; 6.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. 7.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; 8.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; 9.Renal disorders at screening: (1) Unstable or rapidly progressive renal disease; (2) Moderate / severe renal disfunction or end-stage renal disease (eGFR=133 µmol/L(1.5 mg/mL) in men, or >=124 µmol/L (1.4 mg/mL) in women; 10.Other abnormal laboratory test: (1) Hemoglobin 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; 11.The investigator considers that the participant is not able to complete the study process, or the participation is not safe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with favorable outcomes in both treatment and follow-up period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with grade 3 or 4 adverse effect;Time to culture conversion;Proportion of participants with favorable outcomes in treatment period;Proportion of participants with composite favorable outcomes in follow-up period; | — |
Countries
China
Contacts
Public ContactWenhong Zhang
Huashan Hospital, Fudan University
Outcome results
None listed