NCT06057519招募中3 期
Pragmatic Trial on the Safety and Tolerability of an Optimized Dose of Rifampicin in Tuberculosis Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Incidence of hepatotoxicity
研究概览
简要总结
The goal of this clinical trial is to compare an optimized dose (1800 mg) of rifampicin to standard dose (450 mg if patient <50 kg and 600 mg if patient >50kg) of rifampicin in tuberculosis patients.
The main questions it aims to answer are:
- To compare the incidence of hepatotoxicity occurs in the optimized dose vs standard dose arm
- To compare any adverse events occur in the optimized dose vs standard dose arm
- To compare final treatment outcome at the end of treatment according to WHO definitions of cure in the optimized dose regimen versus the standard dose regimen.
- To compare two and three months culture conversion rates in the optimized dose regimen versus the standard dose regimen.
- To describe and compare the steady-state plasma pharmacokinetics of the optimized dose regimen versus the standard dose regimen.
Participants will be given an optimized dose of 1800 mg of rifampicin daily. Researchers will compare the optimized and standard dose to see if more hepatotoxicity occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has provided informed consent for study participation prior to all trial-related procedures.
- •The patient has a diagnosis of pulmonary tuberculosis according to the local diagnostic criteria.
- •The patient is aged 18 years or older at the day of informed consent.
- •No known allergic reactions or toxicity to rifampicin in the past.
- •Female patients of childbearing potential must have a negative serum pregnancy test, and consent to practice an effective method of birth control during the study. And they should not be lactating during the trial (female participants of childbearing potential only). Effective birth control for female patients has to include two methods, including methods that the patient's sexual partner(s) use. At least one must be a barrier method. Female patients are considered not to be of childbearing potential if they are post-menopausal with no menses for the last 12 months, or surgically sterile (this condition is fulfilled by bilateral oophorectomy, hysterectomy, and by tubal ligation which is done at least 12 months prior to enrolment).
- •The patient will be compliant to the study schedule, in the discretion of the investigator.
排除标准
- •The patient has tuberculosis which is assessed to receive high dose rifampicin according to the local standard of care.
- •The patient started current TB treatment more than 4 weeks ago.
- •The patient has TB meningitis.
- •The patient is in a coma.
- •Circumstances that raise doubt about free, uncoerced consent to study participation (e.g. in a prisoner or mentally handicapped person)
- •The patient is not able to give consent personally.
- •Poor general condition or comorbidities where delay in treatment cannot be tolerated or death within three months is likely. Or if there is concurrent treatment that may interfere.
- •The patient is pregnant or breast-feeding.
- •Patient infected with a rifampicin-resistant strain of M. tuberculosis.
- •Known allergy or intolerance for rifamycins.
- •The participant has a known or suspected, current alcohol or drug or amphetamine abuse, that is, in the opinion of the investigator, sufficient to compromise the safety or cooperation of the patient.
- •The patient has a known allergy or intolerance, or concomitant disorders or conditions for which rifamycins or other standard TB treatment drugs are contraindicated.
- •The patient has had treatment with any other investigational drug within 1 month prior to enrolment, or enrolment into other clinical (intervention) trials is planned in the upcoming 6 months
- •Laboratory: at screening one or more of the following abnormalities were observed for the patient in screening laboratory:
- •Serum amino aspartate transferase (AST) and/or serum alanine aminotransferase (ALT) activity >3x the upper limit of normal
- •Serum total bilirubin level >2.5 times the upper limit of normal
- •Creatinine clearance (CrCl) level lower than 30 mls/min
- •Acute or severe or life-threatening liver disease induced by drugs in the past
- •The patient has a chronic disorder such as liver disease or renal disease.
- •The patient has icterus.
- •Previous anti-TB treatment: the patient ended a previous TB treatment (episode) within last 3 months.
研究组 & 干预措施
Optimized dose rifampicin
Experimental
1800 mg flat dose
干预措施: Optimised dose rifampicin (Drug)
Standard dose rifampicin
Active Comparator
450 mg for patients under 50 kg and 600 mg for patients over 50 kg
干预措施: Standard dose rifampicin (Drug)
结局指标
主要结局
Incidence of hepatotoxicity
时间窗: 26 weeks
How often does hepatotoxicity occur in patients with optimized dose rifampicin vs standard dose rifampicin
次要结局
- Adverse events(26 weeks)
- Treatment outcome(26 weeks)
- Culture conversion rate(2 and 3 months post-treatment initiation)
- PK parameter, Tmax(2 Weeks)
- PK parameter, T1/2(2 Weeks)
- PK parameter, AUC0-24(2 Weeks)
- PK parameter, Clearance(2 Weeks)
- PK parameter, Volume of distribution(2 Weeks)
- PK parameter, Cmax(2 Weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study of CL-197 Capsules in Healthy ParticipantsHIV-1NCT05944848HeNan Sincere Biotech Co., Ltd44
Unknown
1 期
Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Anti-tumor Activity of SYHA1801 Monotherapy in Patients With Advanced Solid TumorsAdvanced Solid TumorsNCT04309968CSPC ZhongQi Pharmaceutical Technology Co., Ltd.186
已完成
1 期
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of SIPS-2209-1 in Healthy Korean VolunteersHealthyNCT05787873Samik Pharmaceutical Co. Ltd.40
已完成
1 期
Evaluation of Safety, Tolerability, PK/PD, and Metabolism of Single-Dose Singletine(DC407) in AdultsHealthy SubjectsNCT06160401Guangzhou JOYO Pharma Co., Ltd75
已完成
1 期
Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults.Healthy SubjectsNCT06137911Guangzhou JOYO Pharma Co., Ltd94