Rifampicin resistance tuberculosis
Conditions
Interventions
Group A1:6Bdq+Lfx(Mfx)+Lzd+Cs+Cfz/3-5Lfx(Mfx)+Lzd+Cs+Cfz
Group A2:6Bdq+Mfx(Lfx)+Lzd+Cs+Z/3-5Mfx(Lfx))+Lzd+Cs+Z
Group B1:6Bdq+Am+Lzd+Cs+Cfz/3-5Lzd+Cs+Cfz
Group B2:6Bdq+Lzd+Cs+Cfz+Z/3-5Lzd+Cs+Cfz+Z
Sponsors
Shenyang Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria (all of the following inclusion criteria must be met for inclusion): 1) Be willing to participate in the experimental treatment and follow-up, and have the informed consent signed by or witnessed by the parents or legal guardians; 2) Male or female =6 years old and < 18 years old, weight =16kg; 3) Initial or retreatment of rifampicin-resistant tuberculosis confirmed by Xpert MTB/RIF molecular drug sensitivity test or traditional drug sensitivity diagnosis methods within 90 days (if polar concentration of MTB is detected by Xpert MTB/RIF and RIF is resistant, Xpert MTB/RIF should be tested again to confirm rifampicin resistance); 4) Newly diagnosed fluoroquinolone-sensitive MDR/RR-TB children who have not received or received any of the second-line anti-tuberculosis drugs (betaquinoline, linezolid, cycloserine, clofazimine) in the short-course study regimen for less than 1 month (except for sensitivities to these drugs confirmed by drug sensitivity tests); 5) Newly diagnosed fluoroquinolone-resistant MDR/RR-TB children who have not received or received any of the second-line anti-tuberculosis drugs (Bedaquinoline, linezolid, cycloserine, clofazimine, amicacin) in the short-course study regimen for less than 1 month (except sensitivity to these drugs confirmed by drug sensitivity tests)
Exclusion criteria
Exclusion criteria: Exclusion criteria (those who meet any of the following exclusion criteria will not be included in the group): 1) The patient was proved to be resistant to any of the second-line anti-tuberculosis drugs (Bedaquinoline, linezolid, cycloserine, clofazimine) in the shorter all-oral regimen (except second-line injections or fluoroquinolones); 2) Xpert MTB/XDR proved that the patient was resistant to both second-line injections and fluoroquinolones. 3) In cases with a clear source of infection, drug sensitivity of the source case proved resistant to any of the second-line anti-TB drugs in the shorter all-oral regimen (except second-line injections or fluoroquinolones). 4) Previous history of heart disease, syncope episodes, symptomatic or clinically significant asymptomatic arrhythmias (except sinus arrhythmias); The presence of one or more risk factors for prolonged QTc intervals or other unadjusted risk factors for tip torsion ventricular tachycardia (TdP); Baseline QT interval (QTcF)> 450 ms; 5) Due to severe drug allergy, liver and kidney function diseases, serious systemic diseases, drug contraindications, drug accessibility and other reasons, unable to follow the requirements of this project to form an effective oral short-course therapy program; 6) Severe pulmonary tuberculosis in children and adolescents, including chest imaging findings of bilateral cavities or bilateral extensive lung parenchyma lesions; 7) Severe extrapulmonary tuberculosis in children and adolescents includes hematogenous disseminated tuberculosis and extrapulmonary tuberculosis other than lymph node tuberculosis (peripheral lymphatic tuberculosis or isolated intrathoracic lymph node tuberculosis without compression); 8) The expected survival time judged by the competent physician is not more than 3 months; 9) Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Benign outcome;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactYu Chen
Shenyang Tenth People's Hospital
Outcome results
None listed