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每日服用利福喷汀治疗 LTBI 的安全性、耐受性和有效性评估 (ASTERoiD)

2026年5月4日 更新者：Centers for Disease Control and Prevention

六周每日利福喷丁与 12-16 周利福霉素治疗潜伏性结核分枝杆菌感染的比较组：安全性、耐受性和有效性评估

进行这项研究是为了比较一种为期 6 周的新型短期利福喷汀方案（6wP，实验组）与基于利福霉素的 12-16 周治疗（标准护理，对照组）的安全性和有效性潜伏性结核分枝杆菌感染 (LTBI)。

该试验在进展为结核病 (TB) 的风险增加且需要 LTBI 治疗的人群中进行。 该研究将在美国、英国和其他低至中度结核病发病率（每 100,000 人中 100 例结核病病例）的国家进行，这些国家将 LTBI 治疗作为其护理标准，并提供 12-16 周的利福霉素-基础疗法作为护理标准。

本研究的假设是实验治疗（6wP 组）的安全性和有效性不劣于 12-16 周基于利福霉素治疗 LTBI 的比较组（对照组）。

参与者被登记并随机分配到两个研究组之一：实验 6wP 或对照。 比较（对照）组的治疗方案包括 12 周每周一次的异烟肼 (INH) 和利福喷汀 (3HP)、12 周每天一次的异烟肼和利福平 (3HR) 以及 16 周每天一次的利福平 (4R)。 将招募每组 560 名参与者（总共 1,120 名）进行安全性评估，每组 1,700 名参与者（总共 3,400 名）进行有效性评估，按照随机分配进行治疗，并自研究之日起随访 24 个月注册。

数据收集完成后，将进行统计分析，比较6wP和对照组因药物不良反应（ADR）停药的比例和新诊断结核病的比例。

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

3400

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Amber B Robinson, PhD
  • 电话号码：1-800-CDC-INFO
  • 邮箱：nkj5@cdc.gov

学习地点

  • 乌干达
      • Kampala、乌干达
        • 招聘中
        • Joint Clinical Research Centre/ Makerere Univ Med Sch
        • 接触：
          • Harriet Mayanja, MD
  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T1Y 6H6
        • 招聘中
        • Calgary TB Clinic
        • 接触：
          • Dina Fisher, MD
      • Edmonton、Alberta、加拿大
        • 招聘中
        • Edmonton TB Clinic
        • 接触：
          • Richard Long, MD
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • 招聘中
        • British Columbia Centre for Disease Control
        • 接触：
          • James Johnston, MD
    • Ontario
      • Toronto、Ontario、加拿大、M5P 1N5
        • 招聘中
        • Toronto Western Hospital
        • 接触：
          • Sarah Brode, MD
    • Quebec
      • Montreal、Quebec、加拿大、H3A 0G4
        • 招聘中
        • McGill University Health Centre
        • 接触：
          • Dick Menzies, MD
  • 南非
      • Stellenbosch、南非
        • 尚未招聘
        • Desmond Tutu TB Center
        • 接触：
          • Anneke Hesseling, MD
  • 海地
      • Port-au-Prince、海地
        • 招聘中
        • Les Centres Gheskio (INLR) CRS
        • 接触：
          • Jean Pape, MD
  • 澳大利亚
      • Sydney、澳大利亚
        • 招聘中
        • Royal Prince Alfred Hospital
        • 接触：
          • Greg Fox, MD
      • Sydney、澳大利亚
        • 招聘中
        • Liverpool Hospital
        • 接触：
          • Zinta Harrington, MD
      • Sydney、澳大利亚
        • 招聘中
        • Paramatta Chest
        • 接触：
          • Jin-Gun Cho, MD
  • 美国
    • Colorado
      • Denver、Colorado、美国、80204
        • 招聘中
        • Denver Health and Hospital Authority
        • 接触：
          • Robert Belknap, MD
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20001
        • 招聘中
        • George Washington University
        • 接触：
          • Afsoon Roberts, MD
      • Washington D.C.、District of Columbia、美国、20001
        • 招聘中
        • Washington DC VA Medical Center
        • 接触：
          • Debra Benator, MD
    • New York
      • Manhattan、New York、美国、10001
        • 招聘中
        • New York Harbor Healthcare System
        • 接触：
          • Benjamin Wu, MD
      • New York、New York、美国、11201
        • 招聘中
        • New York City Bureau of TB Control
        • 接触：
          • Joseph Burzynski, MD
    • Texas
      • San Antonio、Texas、美国、78201
        • 主动，不招人
        • San Antonio VA
    • Washington
      • Seattle、Washington、美国、98101
        • 招聘中
        • Seattle King County Health Department
        • 接触：
          • Caitlin Reed, MD
  • 贝宁
      • Cotonou、贝宁
        • 主动，不招人
        • National Referral University Hospital for Pneumo-physiology
  • 越南
      • Ho Chi Minh City、越南
        • 招聘中
        • Ho Chin Minh City-District 6 TB Unit
        • 接触：
          • Greg Fox, MD
      • Ho Chi Minh City、越南
        • 招聘中
        • Ho Chin Minh City-Phoi Viet Resportory Centre
        • 接触：
          • Greg Fox, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

描述

纳入标准：

  • 12 岁以上的男性或未怀孕、未哺乳的女性。 未进行手术绝育的育龄妇女必须同意采用适当的避孕方法（屏障避孕法或非激素宫内节育器）或在研究药物治疗期间避免异性性交。

  • 没有结核病证据且进展为结核病的风险增加的 LTBI 患者。结核分枝杆菌感染可通过阳性结核菌素皮肤试验 (TST) 或阳性干扰素γ释放试验（IGRA；例如，QuantiFERON 或 T.SPOT.TB）来证明。 患有 LTBI 且进展为 TB 的风险增加的人是那些具有以下之一的人：

    1. 入组前 2 年内与培养确诊的结核病患者的家庭和其他密切接触者（一周内暴露时间 > 4 小时） 源病例中的阳性核酸扩增试验 (NAAT)/GeneXpert 可用于文化确认前入学
    2. 最近结核分枝杆菌感染，定义为在入组前 2 年内从记录的阴性转为阳性 TST 或 IGRA。 与 IGRA 转换的活动性肺结核患者没有已知密切接触的人可能需要额外评估以排除假转换。
    3. HIV合并感染。
    4. 胸部 X 光片显示肺实质纤维化≥ 2 cm2，且既往无 TB 或 LTBI 治疗史。
    5. 最近（入组前 2 年内）移民到美国、英国或其他低至中度结核病发病率、胸部 X 光检查异常且无活动性结核病证据的国家。
    6. 最近（入组前 2 年内）从估计结核病发病率 > 150 / 100,000 的国家（见附录 D）移民到美国、英国或其他低至中度结核病发病率的国家。
    7. 由于终末期肾病等医疗状况或使用免疫抑制药物（如慢性类固醇或 TNF-α 抑制剂）导致患结核病的风险增加。
  • 与 TB 病例有密切接触的 HIV 感染者，无论 TST 或 IGRA 结果如何。
  • 愿意提供签署的知情同意书，或父母许可和参与者同意。

排除标准：

  • 当前确认的培养阳性或临床结核病。
  • 疑似当前结核病。 包括无法消除活动性结核病可能性的病例（由现场调查员进行）
  • 源病例中对任何利福霉素耐药的结核病
  • 入组前 2 年内使用利福霉素 > 连续 7 天或 > 连续 30 天使用 INH 的治疗史。
  • 在 HIV 血清反应阴性的人中完成足够的结核病或 LTBI 治疗的历史记录。
  • 对利福霉素过敏或不耐受的历史。
  • 血清丙氨酸氨基转移酶（ALT；SGPT）或血清天冬氨酸氨基转移酶（AST；SGOT）> 基线 ALT 或 AST 确定的人群中正常上限的 5 倍+。
  • 由于药物相互作用，HIV 血清反应呈阳性且正在接受抗逆转录病毒治疗，但不能与利福平或利福喷丁一起使用。
  • 接受已知与任何研究药物禁忌的合并用药。
  • 目前怀孕、哺乳或打算在入学后 120 天内怀孕的女性。
  • 重量 < 25 公斤。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：6 周的每日利福喷丁 (6wP)
利福喷丁每天一次，持续 6 周：600 毫克利福喷丁 (RPT)，每天一次，持续 6 周
药品：每日利福喷丁，持续 6 周
600 毫克利福喷丁 (RPT) 每天一次（o.d.，omni die），持续 6 周 (6wP)。
其他名称：
  • 原告
有源比较器：12-16 周基于利福霉素的方案

参与者所在地提供的基于利福霉素的 12-16 周方案：

“利福喷丁和异烟肼每周一次，持续 12 周”(3HP) 或“利福平和异烟肼每天一次，持续 12 周”(3HR) 或“利福平每天一次，持续 16 周”(4R)
药品：利福喷丁和异烟肼每周一次，持续 12 周

利福喷汀 (RPT) 900 毫克和异烟肼 (INH) 900 毫克，每周一次，持续 12 周 (3HP)。*

*将根据 ATS/CDC/IDSA 指南根据患者体重调整剂量。

对于体重 > 50 公斤的人，每周一次 RPT 900 毫克。 对于体重 < 50 公斤的人，将给予以下剂量：体重 > 25-32 公斤 - RPT 600 毫克；体重 > 32-50 公斤 - RPT 750 毫克； + INH 15 mg/kg（四舍五入到最接近的 50 或 100 mg；最大 900 mg）。

药品：每天服用利福平和异烟肼，持续 12 周

利福平 (RIF) 600 mg 和异烟肼 (INH) 300 mg，每天一次，持续 12 周 (3HR)*。

*将根据 ATS/CDC/IDSA 指南根据患者体重调整剂量。

体重 > 50 公斤的人每天服用 RIF 600 毫克。 对于体重 < 50 公斤的人，每天给予 10 毫克/公斤；四舍五入到最接近的 50 或 100 毫克； + INH 5 mg/kg 每天（四舍五入到最接近的 50 或 100 mg；最大 300 mg）。

药品：每日利福平，持续 16 周

利福平 (RIF) 600 毫克，每天一次，持续 16 周 (4R)。*

*将根据 ATS/CDC/IDSA 指南根据患者体重调整剂量。

体重 > 50 公斤的人每天服用 RIF 600 毫克。 对于体重 < 50 公斤的人，每天 10 毫克/公斤；四舍五入到最接近的 50 或 100 毫克。

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Treatment discontinuation due to adverse drug reaction
大体时间：from the date of enrollment to the date of scheduled completion of assigned treatment

1. Safety: Drug discontinuation due to adverse drug reaction (ADR) associated with 6wP and the rifamycin-based comparator arm (3HP, 3HR, or 4R).

• Attribution of an adverse event (AE) to study drugs will be initially determined by the local site investigator, reviewed by an independent, blinded adjudication panel and with final attribution determined by the sponsor.
from the date of enrollment to the date of scheduled completion of assigned treatment
Culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old.
大体时间：within 24 months from the date of enrollment

2. Effectiveness: Culture-confirmed TB in participants > 18 years old and culture-confirmed or clinical TB in participants < 18 years old.

  • Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media.
  • An independent, blinded adjudication panel will review all TB events.
within 24 months from the date of enrollment

次要结果测量

结果测量
措施说明
大体时间
18 岁以下参与者的安全性（定义为因药物不良反应而停止治疗）。
大体时间：从入组日期到治疗完成的最长接受时间如下：6wP 治疗 9 周，3HP 16 周，3HP 16 周，4R 21 周
因与实验性治疗 (6wP) 或活性对照治疗（基于利福霉素的 3HP、3HR 或 4R）相关的药物不良反应 (ADR) 而停药的 18 岁以下参与者的比例。 研究药物的不良事件 (AE) 归因将由当地现场调查员确定。
从入组日期到治疗完成的最长接受时间如下：6wP 治疗 9 周，3HP 16 周，3HP 16 周，4R 21 周
人类免疫缺陷病毒 (HIV) 感染参与者的耐受性（定义为因任何原因停药的比例）。
大体时间：从入组日期到治疗完成的最长接受时间如下：6wP 治疗 9 周，3HP 16 周，3HP 16 周，4R 21 周
因任何原因停药的 HIV 感染患者比例
从入组日期到治疗完成的最长接受时间如下：6wP 治疗 9 周，3HP 16 周，3HP 16 周，4R 21 周
18 岁以下参与者的耐受性（定义为因任何原因停药的比例）。
大体时间：从入组日期到治疗完成的最长接受时间如下：6wP 治疗 9 周，3HP 16 周，3HP 16 周，4R 21 周
因任何原因停药的 18 岁以下参与者的比例
从入组日期到治疗完成的最长接受时间如下：6wP 治疗 9 周，3HP 16 周，3HP 16 周，4R 21 周
人类免疫缺陷病毒 (HIV) 感染参与者的有效性。
大体时间：自入学之日起24个月内
18 岁及以上参与者中感染 HIV 的经培养确诊结核病 (TB) 患者的比例，以及 18 岁以下参与者中经培养确诊或临床结核病患者的比例。 培养确诊的结核病诊断将使用液体和/或固体培养基方法进行。
自入学之日起24个月内
参与者 < 18 岁的有效性。
大体时间：自入学之日起24个月内
18 岁以下患有培养确诊的结核病或临床结核病的参与者比例。 培养确诊的结核病诊断将使用液体和/或固体培养基方法进行。
自入学之日起24个月内
Proportion who complete assigned treatment
大体时间：from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of participants who complete assigned study treatment during the study period. Treatment completion is defined as taking at least 90% of the prescribed doses within the protocol-defined time period.
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of Participants Who Complete Assigned Study Treatment
大体时间：from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of participants who complete assigned study treatment during the study period. Treatment completion is defined as taking at least 90% of the prescribed doses within the protocol-defined time period.
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion with any grade 3, 4, or 5 (i.e., death) adverse event associated with study drug
大体时间：within 6 months from the date of enrollment
Proportion of participants who experience at least one Grade 3, 4, or 5 adverse event related to study drug during the study period. Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death). Relationship to study drug will be determined by the site investigator and reviewed by an independent blinded adjudication panel.
within 6 months from the date of enrollment
Proportion of Participants Who Die From Any Cause
大体时间：within 24 months from the date of enrollment
Proportion of participants who die from any cause during the study period. Deaths will be ascertained through participant follow-up, medical records, or death registries and reviewed by an independent blinded adjudication panel.
within 24 months from the date of enrollment
Proportion of Participants With Hepatotoxicity or Non-Hepatotoxic Systemic Drug Reactions
大体时间：within 6 months from the date of enrollment
Proportion of participants who experience at least one event of hepatotoxicity or non-hepatotoxic systemic drug reaction during the study period. Hepatotoxicity and systemic drug reactions will be defined per protocol and graded using Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Relationship to study drug will be determined by the investigator.
within 6 months from the date of enrollment
Proportion of Participants with Culture-Confirmed or Clinical Tuberculosis (TB)
大体时间：within 24 months from the date of enrollment
Proportion of participants who develop culture-confirmed or clinical tuberculosis (TB) during the study period, regardless of age. Culture-confirmed TB will be based on microbiological confirmation using liquid and/or solid culture methods. Clinical TB will be defined according to protocol-specified diagnostic criteria and adjudicated by an independent blinded panel.
within 24 months from the date of enrollment
Proportion of Participants Who Develop Tuberculosis (TB) Among Those Who Complete Assigned Study Treatment
大体时间：within 24 months from the date of enrollment
Proportion of participants who develop tuberculosis (TB) among those who complete assigned study treatment during the study period. Completion of treatment is defined per protocol. TB will be defined as culture-confirmed or clinical TB based on microbiological or protocol-specified clinical criteria and reviewed by an independent blinded adjudication panel.
within 24 months from the date of enrollment
Proportion of Participants With HIV Infection Who Discontinue Study Treatment Due to Adverse Drug Reactions
大体时间：from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of HIV-infected patients with drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R) . Attribution of an adverse event (AE) to study drugs will be determined by the local site investigator.
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion with any grade 3, 4, or 5 (i.e., death) adverse event during the time period of 6 months after enrollment
大体时间：within 6 months from the date of enrollment
Proportion of participants who experience at least one Grade 3, 4, or 5 adverse event within 6 months after enrollment. Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 (Grade 3 = severe, Grade 4 = life-threatening, Grade 5 = death).
within 6 months from the date of enrollment
Effectiveness among pregnant participants
大体时间：within 24 months from the date of enrollment
Proportion of pregnant participants with culture-confirmed tuberculosis or clinical TB. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.
within 24 months from the date of enrollment
Safety (defined as treatment discontinuation due to adverse drug reaction) among pregnant participants.
大体时间：from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of pregnant participants with drug discontinuation due to adverse drug reaction (ADR) associated with experimental treatment (6wP) or active comparator treatment (the rifamycin-based 3HP, 3HR, or 4R) .
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Tolerability (defined as proportion of with drug discontinuation for any reason) among pregnant participants
大体时间：from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of pregnant participants with drug discontinuation for any reason
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R

其他结果措施

结果测量
措施说明
大体时间
Proportion of Participants Who Discontinue Study Treatment Due to Adverse Drug Reactions by Treatment Arm
大体时间：from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of participants who permanently discontinue study treatment due to adverse drug reactions (ADRs), summarized separately for the experimental arm (6wP) and each comparator regimen (3HP, 3HR, and 4R). Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0, and attribution to study drug will be determined by the investigator and reviewed by an independent blinded adjudication panel.
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of Participants Who Discontinue Study Treatment for Any Reason by Treatment Regimen
大体时间：from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of participants who discontinue study treatment for any reason during the study period, summarized separately for the experimental arm (6wP) and each comparator regimen (3HP, 3HR, and 4R).
from date of enrollment until the maximum accepted time for treatment completion as follows: 9 weeks for 6wP treatment, 16 weeks for 3HP, 16 weeks for 3HP, and 21 weeks for 4R
Proportion of Participants Who Develop Tuberculosis (TB) by Treatment Regimen
大体时间：within 24 months from the date of enrollment
Proportion of participants with culture-confirmed tuberculosis (TB) in participants 18 years old and older and culture-confirmed or clinical TB in participants less then 18 years old. Diagnosis of culture-confirmed TB will be performed using liquid and/or solid media methods.
within 24 months from the date of enrollment
Proportion of Participants With Drug-Resistant Tuberculosis (TB) Among Those Who Develop TB by Comparator Regimen
大体时间：within 24 months from the date of enrollment
Proportion of participants who develop tuberculosis (TB) and have resistance to rifamycins or isoniazid, summarized separately for each comparator regimen (3HP, 3HR, and 4R). Drug resistance will be determined by phenotypic drug susceptibility testing of Mycobacterium tuberculosis isolates.
within 24 months from the date of enrollment
Treatment Acceptability Score (Likert-Scale TB Treatment Acceptability Questionnaire)
大体时间：within 24 months from the date of enrollment

Participant-reported treatment acceptability score assessed using a Likert-scale tuberculosis (TB) treatment acceptability questionnaire evaluating domains including usability, treatment duration, pill burden, perceived risks versus benefits, and opportunity cost.

  • Scale range: 6 to 30
  • Interpretation: Higher scores indicate greater treatment acceptability
within 24 months from the date of enrollment
Health-Related Quality of Life Score (PROMIS-29+2 [PROPr] and PROMIS Pediatric Profile)
大体时间：within 24 months from the date of enrollment

Health-related quality of life (HrQoL) assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS-29+2 Profile v2.1 [PROPr] for adults and PROMIS Pediatric Profile v3). Scores include physical and mental health component scores derived from PROMIS domains.

  • Scale range: 0 to 100 (standardized T-scores; mean 50, SD 10)
  • Interpretation: Higher scores indicate better health-related quality of life
within 24 months from the date of enrollment
Area Under the Plasma Concentration-Time Curve (AUC₀-₂₄) of Rifapentine in Participants Receiving 6wP
大体时间：within 24 months from the date of enrollment
Population pharmacokinetic parameter AUC₀-₂₄ of rifapentine estimated using nonlinear mixed-effects modeling based on plasma concentration data collected in participants receiving 6 weeks of daily rifapentine (6wP). Unit: µg·h/mL
within 24 months from the date of enrollment
Correlation Between Rifapentine AUC₀-₂₄ and Treatment Discontinuation Due to Adverse Drug Reactions
大体时间：within 24 months from the date of enrollment
Correlation between rifapentine area under the plasma concentration-time curve from 0 to 24 hours (AUC₀-₂₄; µg·h/mL), measured using validated LC-MS/MS assays, and treatment discontinuation due to adverse drug reactions (% of participants) among participants receiving 6 weeks of daily rifapentine (6wP). Adverse drug reactions will be assessed by the investigator and graded using CTCAE v5.0.
within 24 months from the date of enrollment
Correlation Between Rifapentine AUC₀-₂₄ and Treatment Completion
大体时间：Within 24 months from the date of enrollment
Correlation between rifapentine area under the plasma concentration-time curve from 0 to 24 hours (AUC₀-₂₄; µg·h/mL), measured using validated LC-MS/MS assays, and treatment completion (% of participants completing assigned treatment per protocol) among participants receiving 6 weeks of daily rifapentine (6wP).
Within 24 months from the date of enrollment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Centers for Disease Control and Prevention

合作者

British Medical Research Council

调查人员

  • 学习椅：Timothy Sterling, MD、Vanderbilt University Medical Center
  • 学习椅：Robert Belknap, MD、Denver Public Health (USA)
  • 研究主任：Amber Robinson, PhD、Centers for Disease Control and Prevention
  • 研究主任：Rosanna M Boyd, PhD、Centers for Disease Control (USA)
  • 学习椅：Dick Menzies, MD、McGill University

出版物和有用的链接

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有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2019年8月1日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2029年12月31日

研究注册日期

首次提交

2018年3月8日

首先提交符合 QC 标准的

2018年3月15日

首次发布 (实际的)

2018年3月22日

研究记录更新

最后更新发布 (实际的)

2026年5月6日

上次提交的符合 QC 标准的更新

2026年5月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CDC-NCHSTP-7024

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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