Overview
Innovating Shorter, All- Oral, Precised, Individualized Treatment Regimen for Rifampicin Resistant Tuberculosis:Contezolid, Delamanid and Bedaquiline Cohort
Status:
Recruiting
Recruiting
Trial end date:
2026-12-31
2026-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are: - Is the efficacy of short regimen non-inferior to standard regimen? - Is the short regimen safe enough to replace the standard regimen? Participants will: - Be given with either short or standard regimen for RR-TB treatment - Be asked to complete the scheduled visit as planned.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Beijing Chest HospitalCollaborator:
National Medical Center for Infectious DiseasesTreatments:
Aminosalicylic Acid
Bedaquiline
Clofazimine
Cycloserine
Ethambutol
Levofloxacin
Linezolid
Moxifloxacin
Prothionamide
Pyrazinamide
Criteria
Inclusion criteria:1. Age ≥18y and <70y when signing informed consent;
2. Initial or re-treatment for pulmonary tuberculosis with:
1) MTB positive in sputum or bronchoalveolar lavage fluid culture at or within 3 months
before screening, or MTB positive in molecular test at or within 3 months before screening,
and; 2) recorded Rifampicin-resistance at or before screening; 3. Imaging (Chest X-ray or
CT scan) proved pulmonary tuberculosis within 1 year before screening; 4. Never used BDQ,
DLM or CZD, or the accumulative duration of any of the treatment is not more than 2 weeks
5. For women in childbearing age, negative in pregnancy test and effective contraceptive
measures throughout study is required; 6. For men, effective contraceptive measures is
required; 7. Willing to participate the study and sign informed consent.
Exclusion criteria:
1. The participant will be excluded by investigator based on the medical history or
concomitant diseases such as serious metabolic disease, cardiovascular disease,
hepatobiliary disease, renal disease, autoimmune disease, neuropsychiatric disorders,
hematological disease, malignant neoplastic disease and so on; or the study will have
negative impact on the well-being of the participant, or the participant is considered
unable to complete the evaluation by investigator;
2. History of alcohol or drug abuse that the study is considered have negative impact on
the well-being of the participant by investigator;
3. HIV positive;
4. Chronic hepatitis with HBsAg, HBeAg and anti-HBC antibody positive, or HBV-DNA>1000
CPs/mL with rising ALT/AST;
5. Allergic to or known hypersensitive to any of study drugs;
6. Extensive (or advanced) pulmonary TB disease: presence of bilateral cavitary disease
or extensive parenchymal damage on chest radiography;
7. Hematogenous disseminated pulmonary tuberculosis and serious extrapulmonary
tuberculosis (such as tuberculosis in digestive system, urogenital system,
osteoarticular tuberculosis, tuberculous meningitis);
8. With any of following risk factors for cardiovascular disease: 1) history of
arrhythmia and on consequential treatment; 2) QTcF>500ms on ECG; 3) history of
ventricular arrhythmia; 4) torsade de pointe with heart failure, hypokalemia or
familial long Q-T syndrome; 5) other possible risk factor for arrythmia;
9. Previous or current optic nerve disorder that may progress or deteriorate during the
study by investigator's consideration;
10. Was enrolled within 2 months before screening, or currently in other studies; except
for those who participating observational study or in the post-treatment period;
11. Being considered unlikely to survive for more than 6 months by investigator;
12. BMI < 17kg/m2
13. May need surgical procedures based on the evaluation of pulmonary lesions;
14. May continuous use prohibited concomitant medications that is considered not suitable
for the study by investigator;
15. Positive in pregnancy test or known pregnancy, breastfeeding, or plan to become
pregnant during or within 6 months after the study treatment;
16. Abnormal laboratory test results: 1) Plasma potassium lower than lower limit of normal
(LLN); 2) Hb < 8.0 g/dL; 3) platelet count <75,000/mm3; 4) WBC count<3000/mm3;
5)AST/ALT >3×ULN; 6)creatinine>2×ULN;7)total bilirubin>2×ULN, or >1.5×ULN,with
abnormal AST or ALT; 8) Albumin < 30g/L