6 Months of Bedaquiline, Delamanid, Linezolid and Levoffoxacin in RR-TB Patients in Hubei Province
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 52
- Primary Endpoint
- End of treatment outcome
Study Overview
Brief Summary
This study aims to compare the efficacy and safety of a 6-month all-oral regimen including Bedaquiline (BDQ,B), Delamanid (DLM,D), Linezolid (LZD, L), and Levofloxacin (LFX,L) to the the standard long - course treatment regimen within the Chinese population. 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.
Detailed Description
Research Methodology:
Research Subjects: A total of 26 patients with RR - TB/MDR - TB pulmonary tuberculosis undergoing ultra - short - course treatment and 26 patients undergoing standard long - course treatment, whose conditions were confirmed by molecular biology detection techniques or tuberculosis drug susceptibility test results.
Research Methods:
- Treatment Protocol Control Group (Group A): 6 BDQ LZD LFX CS CFZ / 12 LFX CS CFZ Experimental Group (Group B): 6 BDQ DLM LZD LFX
- In - patient and Out - patient Treatment Both in - patient and out - patient treatments are acceptable for patients. However, it is advisable for patients to be hospitalized for a period at the beginning of treatment to ensure they can follow this treatment protocol. Hospitalization can also be arranged when adverse events occur during treatment.
Medical staff are responsible for the treatment management of patients, with the following duties:
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with pulmonary tuberculosis that is resistant to rifampin (RIF) or to both RIF and isoniazid who initiate an all-oral treatment regimen (short or long) under routine or operational conditions will be included.
- •Aged between 18 and 65 years old.
- •Have never used bedaquiline, delamanid, linezolid, or levofloxacin in the past, or have used them for no more than 4 weeks.
- •Positive results of mycobacterial culture (either smear-positive or smear-negative) within the recent one month, and no effective anti-tuberculosis treatment received within this one-month period; or in the absence of recent sputum culture results, smear-positive sputum and no effective anti-tuberculosis treatment administered.
- •No history of respiratory failure or cardiac insufficiency, and no clinically significant arrhythmia manifestations on electrocardiogram.
- •During the treatment and follow - up periods, patients are required to take medications as per the research project requirements, complete treatment monitoring, and promptly report any adverse reactions to the attending physicians.
- •Voluntarily participate in this study and sign the informed consent form.
Exclusion Criteria
- •Individuals with a history of optic neuropathy or peripheral neuropathy, whom the researchers believe may experience progression/worsening during the study or are not suitable for participation in this research.
- •Chronic active hepatitis, with positive results for three items: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and hepatitis B core antibody (anti - HBc), or HBV - DNA > 1000 CPs/mL, accompanied by elevated ALT/AST. Elevation of ALT or AST is ≥3 times the upper limit of the normal value, or elevation of total bilirubin and direct bilirubin is ≥2 times the upper limit of the normal value (if it is a temporary elevation, patients can be enrolled after recovery from treatment).
- •Severe renal insufficiency (creatinine clearance rate (CrCl) less than 30 mL/min).
- •Individuals who have participated in clinical trials of other unlisted new drugs within the past three months.
- •Known congenital QT interval prolongation, presence of any disease that can prolong the QT interval, or a QTc > 450 ms.
- •Pregnant women or women who may be pregnant.
- •Any cardiac diseases capable of inducing arrhythmia, such as severe hypertension (poorly controlled blood pressure), left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure accompanied by a reduced left ventricular ejection fraction.
- •A history of known, untreated, and persistent hypothyroidism. Combined with hematogenous disseminated tuberculosis and central nervous system tuberculosis.
- •A history of allergy or a known allergy to any investigational medicinal product or related substances.
- •HIV-positive.
Arms & Interventions
test group
6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen
Interventions:
Drug: bedaquiline Drug: delamanid Drug: linezolid Drug: Levofloxacin
Intervention: bedaquiline (Drug)
test group
6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen
Interventions:
Drug: bedaquiline Drug: delamanid Drug: linezolid Drug: Levofloxacin
Intervention: Delamanid (DLM) (Drug)
test group
6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen
Interventions:
Drug: bedaquiline Drug: delamanid Drug: linezolid Drug: Levofloxacin
Intervention: Linezolid (LZD) (Drug)
test group
6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) , as known as BDLL regimen
Interventions:
Drug: bedaquiline Drug: delamanid Drug: linezolid Drug: Levofloxacin
Intervention: Levofloxacin (Drug)
Control group (Group A)
Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.
Intervention: bedaquiline (Drug)
Control group (Group A)
Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.
Intervention: Delamanid (DLM) (Drug)
Control group (Group A)
Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.
Intervention: Linezolid (LZD) (Drug)
Control group (Group A)
Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.
Intervention: Levofloxacin (Drug)
Control group (Group A)
Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.
Intervention: Cycloserine (Drug)
Control group (Group A)
Six months of bedaquiline, linezolid, levofloxacin, cycloserine, and clofazimine, followed by 12 months of levofloxacin, cycloserine, and clofazimine.
Intervention: Clofazimine (Drug)
Outcomes
Primary Outcomes
End of treatment outcome
Time Frame: 72 weeks after the treatment initiation
Number of individuals experiencing each tuberculosis treatment outcome (cure, completion, death, failure, lost-to-follow-up), assessed at the end of treatment by a clinician, based on culture results
Secondary Outcomes
- The median time to Sputum Culture Conversion(Time Frame: 4-24 weeks after treatment initiation)
- Final tuberculosis treatment outcome(24, 48 and 72 weeks after treatment completion)
Investigators
Yan Hu
Shuang Wei,Vice-President
Wuhan Pulmonary Hospital