Status:
NOT_YET_RECRUITING
6 Months of Bedaquiline(BDQ), Delamanid(DLM), Linezolid(LZD) and Levofloxacin(LFX) in RR-TB Patients in Hubei Province
Lead Sponsor:
Wuhan Pulmonary Hospital
Conditions:
Treat to Target
Treatment Duration
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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 - cou...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT07198685
Start Date
September 30 2025
End Date
September 30 2028
Last Update
September 30 2025
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