이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

A Trial of Stratified Patient-Centered Treatment Regimens for Active TB (SPECTRA-TB)

2026년 5월 12일 업데이트: National Institute of Allergy and Infectious Diseases (NIAID)

A Phase 2C Trial of Stratified Patient-Centered Treatment Regimens for Active TB

The A5414 study will evaluate whether treatment for drug-susceptible pulmonary tuberculosis (TB) can be tailored according to a participant's risk of an unfavorable outcome. Participants will be assigned to lower-risk or higher-risk groups using baseline characteristics and then randomized within each group to receive either standard TB treatment or an investigational rifapentine- and moxifloxacin-containing regimen. The study will evaluate whether shorter treatment durations may be used in lower-risk participants and whether the investigational regimen may improve outcomes in higher-risk participants. Safety and tolerability will also be evaluated.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

SPECTRA-TB is a Phase 2C, randomized, open-label trial of stratified medicine principles in TB treatment to identify the optimal duration of the HP1500ZM regimen for participants in the lower-risk stratum and to demonstrate improved TB-related favorable outcomes of this regimen in the higher-risk stratum. The study risk stratification includes a higher-risk group (1 control arm and 1 experimental arm) and a lower-risk group (1 control and 5 experimental arms).

Eligible participants will be stratified as either lower- or higher-risk based on the risk stratification algorithm which is based on the following results obtained during the screening period: Xpert MTB/RIF Ultra CT value, extent of disease on chest X-ray, age, BMI, sex at birth, diabetes status, and HIV status using the SPECTRA-TB risk algorithm prior to randomization. Those classified into the lower-risk group (consisting of the low and moderate risk randomization strata to facilitate balancing of risk within each lower-risk treatment arm) will be randomized to SOC or one of five durations of the experimental regimens while those classified into the higher-risk group will be randomized to receive either SOC or a single fixed duration of the experimental regimen. The lower and higher-risk groups will have the following arms:

  • Lower-risk: 10, 12, 14, 16, 18, and 26 weeks (5 experimental arms [weeks 10-18] and one 26-week SOC arm with 100 participants in each arm).
  • Higher-risk: Two arms with 26 weeks duration (one SOC arm with 100 participants and one experimental arm with 200 participants).

All participants will be followed for 72 weeks from randomization for outcomes of efficacy, safety, and tolerability. Participants will be monitored closely for Possible Poor Treatment Response (PPTR), TB treatment failure or TB recurrence, safety, tolerability, and loss to follow-up.

연구 유형

중재적

등록 (추정된)

900

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 말라위
      • Blantyre, 말라위
        • Blantyre CRS (Site #: 30301)
        • 연락하다:
          • Dumisile Huwa
          • 전화번호: 265-1811885
          • 이메일: dhuwa@jhp.mw
    • Central Region
      • Lilongwe, Central Region, 말라위
  • 멕시코
      • Mexico City, 멕시코, 14000
        • Nutrición-Mexico CRS (Site #: 32078)
        • 연락하다:
  • 베트남
      • Hanoi, 베트남, 100000
        • National Lung Hospital (Site #: 32483)
        • 연락하다:
  • 보츠와나
      • Gaborone, 보츠와나
        • Gaborone CRS (Site #: 12701)
        • 연락하다:
      • Gaborone, 보츠와나
        • Molepolole CRS (Site # 12702)
        • 연락하다:
  • 브라질
      • Rio Grande, 브라질
        • Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site # 12201)
        • 연락하다:
      • Rio de Janeiro, 브라질, 21040-360
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site #: 12101)
        • 연락하다:
  • 아르헨티나
  • 아이티
      • Port-au-Prince, 아이티, HT-6110
        • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site #: 31730)
        • 연락하다:
      • Port-au-Prince, 아이티, HT-6110
        • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site #: 30022)
        • 연락하다:
  • 우간다
      • Kampala, 우간다, 10005
        • Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site (Site #: 12401)
        • 연락하다:
          • Sandra Rwambuya, M.P.H.
          • 전화번호: 256-772-779283
          • 이메일: dxr23@case.edu
      • Kampala, 우간다
        • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site # 30293)
        • 연락하다:
  • 인도
      • Chennai, 인도
        • YRG CARE CRS (Site # 32075)
        • 연락하다:
    • Maharashtra
      • Pune, Maharashtra, 인도, 411001
        • Byramjee Jeejeebhoy Government Medical College (BJGMC) CRS (Site #: 31441)
        • 연락하다:
  • 짐바브웨
      • Harare, 짐바브웨, 263663
        • Milton Park CRS (Site #: 30313)
        • 연락하다:
  • 케냐
    • Rift Valley
      • Eldoret, Rift Valley, 케냐, 30100
        • Moi University Clinical Research Center (MUCRC) CRS (Site #: 12601)
        • 연락하다:
      • Kericho, Rift Valley, 케냐, 20200
        • Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site #: 12501)
        • 연락하다:
  • 탄자니아
      • Moshi, 탄자니아
        • Kilimanjaro Christian Medical Centre (KCMC) (Site # 5118)
        • 연락하다:
  • 태국
      • Bangkok, 태국
        • Siriraj Hospital, Mahidol University NICHD CRS (Site # 5115)
        • 연락하다:
      • Chiang Mai, 태국, 50200
        • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site #: 31784)
        • 연락하다:
          • Daralak Tavornprasit, R.N., M.Sc.
          • 전화번호: 176 66-5-3936148
          • 이메일: daralak.t@cmu.ac.th
      • Chiang Rai, 태국
        • Chiangrai Prachanukroh Hospital NICHD CRS (Site # 5116)
        • 연락하다:
    • Bangkok
      • Pathum Wan, Bangkok, 태국, 10330
        • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site #: 31802)
        • 연락하다:
  • 페루
      • Callao, 페루
        • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site # 31970)
        • 연락하다:
      • Lima, 페루
        • Barranco CRS (Site #: 11301)
        • 연락하다:
      • Lima, 페루
      • Lima, 페루
        • Socios en Salud Sucursal Peru CRS (Site # 31985)
        • 연락하다:
  • 필리핀 제도
    • Cavite
      • Dasmariñas, Cavite, 필리핀 제도, 4114
        • TB HIV Innovations and Clinical Research Foundation Corp. (Site #: 31981)
        • 연락하다:
  • 호주

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • Has pulmonary tuberculosis (TB) that is likely to respond to standard TB medicines (drug-susceptible TB), based on sputum testing done within 7 days before entering the study. The test must show Mycobacterium tuberculosis is present, with no rifamycin resistance detected and no known resistance to isoniazid or fluoroquinolones.
  • Has a SPECTRA-TB risk score and risk group assigned during screening using the study-specific calculator.
  • Has a Karnofsky performance score of 50 or higher within 30 days before entering the study.
  • Has documented HIV-1 status (either with HIV or without HIV) based on acceptable testing.
  • If living with HIV, has a CD4+ cell count of at least 50 cells/mm3 within 60 days before study entry.
  • If living with HIV, is currently receiving or plans to start an efavirenz-based or dolutegravir-based antiretroviral therapy regimen by study week 8.

  • Has laboratory test results within 7 days before study entry that meet all of the following:

    • alanine aminotransferase (ALT) no more than 3 times the upper limit of normal
    • total bilirubin no more than 2.5 times the upper limit of normal
    • creatinine no more than 2 times the upper limit of normal
    • potassium between 3.5 and 5.5 mEq/L
    • absolute neutrophil count at least 1000/mm3
    • hemoglobin at least 7.0 g/dL
    • platelet count at least 100,000/mm3
  • If able to become pregnant, has a negative blood or urine pregnancy test within 7 days before study entry.

  • If able to become pregnant and sexually active in a way that could lead to pregnancy, agrees not to try to become pregnant and agrees to use at least 1 reliable non-hormonal birth control method during study treatment and for 30 days after stopping study drugs. Acceptable methods include:

    • condoms
    • intrauterine device (IUD) or intrauterine system (IUS)
    • cervical cap with spermicide
    • diaphragm with spermicide
  • If not able to become pregnant, has a history or documentation of menopause, hysterectomy, bilateral removal of the ovaries, or bilateral tubal ligation.
  • Has a verifiable address or place of residence and is willing to tell the study team about any change of address during treatment and follow-up.
  • Is willing and able to give informed consent, or assent with permission from a parent or legal guardian if required.

Exclusion Criteria:

  • TB bacteria are known to be resistant to 1 or more of the following medicines: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones.
  • Received more than 5 days of treatment for active TB within the 24 weeks before study entry.
  • Received more than 5 days of treatment within the 30 days before study entry with certain TB medicines or related antibiotics, including isoniazid, rifampin, rifapentine, ethambutol, moxifloxacin, pyrazinamide, aminoglycosides, fluoroquinolones, linezolid, bedaquiline, pretomanid, and other specified anti-TB drugs.
  • Has suspected or confirmed TB involving the brain or central nervous system, bones, joints, heart lining (pericardium), or miliary TB.
  • Has a past history of suspected or confirmed drug-resistant TB of any type.
  • Is currently pregnant or breastfeeding.
  • Cannot take medicines by mouth.
  • Has an HIV/AIDS-related opportunistic infection at study entry.
  • Has acute or chronic hepatitis B, unless the hepatitis B infection has cleared.
  • Has acute or chronic hepatitis C, unless the hepatitis C infection has cleared or has been successfully treated.
  • Has alcohol-related liver disease.
  • Has liver cirrhosis.
  • Has a history of aortic aneurysm or aortic dissection.
  • Has a known history of long QT syndrome, a first-degree relative with long QT syndrome, or a screening ECG showing QTcF greater than 470 ms that does not correct with treatment of contributing factors.
  • Is taking other medicines that can prolong the QT interval and cannot safely switch to an alternative medicine.
  • Has a known history of acute intermittent porphyria.
  • Weighs less than 30 kg.
  • Is currently using, or is expected to need within 24 weeks after enrollment, 1 or more medicines that are not allowed during the study.
  • Has a known allergy, sensitivity, or hypersensitivity to any of the study drugs or their ingredients.
  • Has active drug or alcohol use, dependence, mental illness, or another serious infection that, in the opinion of the site investigator, could make it hard to follow the study requirements.
  • Is currently taking part in another interventional clinical trial.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Arm 1A: Higher-risk control group
Participants at higher risk of unfavorable outcome will receive 26 weeks of standard-of-care treatment consisting of isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by isoniazid and rifampin for 18 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Rifampin
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Ethambutol
Administered orally once daily
실험적: Arm 1B: Higher-risk experimental group
Participants at higher risk of unfavorable outcome will receive 26 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Rifapentine
Administered orally once daily
의약품: Moxifloxacin
Administered orally once daily
활성 비교기: Arm 2A: Lower-risk control group
Participants at lower risk of unfavorable outcome will receive 26 weeks of standard-of-care treatment consisting of isoniazid, rifampin, pyrazinamide, and ethambutol for 8 weeks, followed by isoniazid and rifampin for 18 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Rifampin
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Ethambutol
Administered orally once daily
실험적: Arm 2B: Lower-risk experimental group (10 week duration)
Participants at lower risk of unfavorable outcome will receive 10 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Rifapentine
Administered orally once daily
의약품: Moxifloxacin
Administered orally once daily
실험적: Arm 2C: Lower-risk experimental group (12 week duration)
Participants at lower risk of unfavorable outcome will receive 12 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Rifapentine
Administered orally once daily
의약품: Moxifloxacin
Administered orally once daily
실험적: Arm 2D: Lower-risk experimental group (14 week duration)
Participants at lower risk of unfavorable outcome will receive 14 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Rifapentine
Administered orally once daily
의약품: Moxifloxacin
Administered orally once daily
실험적: Arm 2E: Lower-risk experimental group (16 week duration)
Participants at lower risk of unfavorable outcome will receive 16 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Rifapentine
Administered orally once daily
의약품: Moxifloxacin
Administered orally once daily
실험적: Arm 2F: Lower-risk experimental group (18 week duration)
Participants at lower risk of unfavorable outcome will receive 18 weeks of the HP1500ZM regimen consisting of rifapentine 1500 mg once daily, moxifloxacin 400 mg once daily, and isoniazid 300 mg once daily, with weight-based pyrazinamide during the first 8 weeks.
의약품: Isoniazid
Administered orally once daily
의약품: Pyrazinamide
Administered orally once daily
의약품: Rifapentine
Administered orally once daily
의약품: Moxifloxacin
Administered orally once daily

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Lower-risk group: Proportion of participants with sustained cure at 52 weeks after randomization
기간: 52 weeks after randomization
Sustained cure is defined as: participant known to be alive at or after 52 weeks after randomization; sustained culture negativity at 52 weeks after randomization, defined as the last 2 liquid cultures collected at different visits being Mtb-negative without an intervening Mtb-positive result, with the last collected no earlier than 48 weeks after randomization; no treatment failure or relapse through 52 weeks after randomization; and no retreatment or additional TB treatment beyond assigned study treatment through 52 weeks after randomization. Participants will be classified as having presence of sustained cure, absence of sustained cure, or not assessable.
52 weeks after randomization
Lower-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization
기간: Baseline through 28 weeks after randomization
Occurrence of at least 1 new Grade 3 to 5 adverse event during the 28 weeks following randomization among participants in the lower-risk group, where 28 weeks is 2 weeks beyond the longest scheduled treatment duration of 26 weeks.
Baseline through 28 weeks after randomization

2차 결과 측정

결과 측정
측정값 설명
기간
Higher-risk group: Proportion of participants with sustained cure at 52 week after randomization
기간: 52 weeks after randomization
Sustained cure is defined as: participant known to be alive at or after 52 weeks after randomization; sustained culture negativity at 52 weeks after randomization, defined as the last 2 liquid cultures collected at different visits being Mtb-negative without an intervening Mtb-positive result, with the last collected no earlier than 48 weeks after randomization; no treatment failure or relapse through 52 weeks after randomization; and no retreatment or additional TB treatment beyond assigned study treatment through 52 weeks after randomization. Participants will be classified as having presence of sustained cure, absence of sustained cure, or not assessable.
52 weeks after randomization
Higher-risk group: Proportion of participants with at least 1 new Grade 3 to 5 adverse event through 28 weeks after randomization
기간: Baseline through 28 weeks after randomization
Occurrence of at least 1 new Grade 3 to 5 adverse event during the 28 weeks following randomization among participants in the higher-risk group, where 28 weeks is 2 weeks beyond the longest scheduled treatment duration of 26 weeks.
Baseline through 28 weeks after randomization
Proportion of participants with sustained cure at 72 weeks after randomization
기간: 72 weeks after randomization
Sustained cure defined as for the primary efficacy outcome measure, except assessed with respect to 72 weeks.
72 weeks after randomization
Cumulative proportion of stable liquid mycobacterial culture conversion by 26 weeks after randomization
기간: Baseline through 26 weeks after randomization
Stable culture conversion is defined as two negative cultures on two different days without an intervening positive culture (irrespective of positive cultures subsequent to stable culture conversion).
Baseline through 26 weeks after randomization
Mean liquid mycobacterial culture log10 days to positivity slope during the first 10 weeks after randomization
기간: During the first 10 weeks after randomization
Liquid mycobacterial culture days to positivity during the 10 weeks following randomization.
During the first 10 weeks after randomization
Proportion of participants who prematurely discontinue study treatment
기간: Baseline through 26 weeks after randomization
Occurrence of premature study treatment discontinuation for any reason other than when the participant has tuberculosis subsequently determined to be resistant to isoniazid, rifampicin, or fluoroquinolones.
Baseline through 26 weeks after randomization

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

National Institute of Allergy and Infectious Diseases (NIAID)

협력자

ViiV Healthcare

수사관

  • 연구 의자: Susan Dorman, MD, Medical University of South Carolina
  • 연구 의자: Gustavo Velásquez, MD, MPH, University of California, San Francisco
  • 연구 의자: Patrick Phillips, PhD, San Francisco General Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 5일

기본 완료 (추정된)

2029년 6월 5일

연구 완료 (추정된)

2029년 10월 22일

연구 등록 날짜

최초 제출

2026년 5월 6일

QC 기준을 충족하는 최초 제출

2026년 5월 12일

처음 게시됨 (실제)

2026년 5월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 19일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 12일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • A5414
  • 38987 (기타 식별자: DAIDS-ES ID)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

Individual participant data that underlie results in the publication, after deidentification.

IPD 공유 기간

Beginning 3 months following publication and available throughout period of funding of the ACTG (Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections) by NIH.

IPD 공유 액세스 기준

  • With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the ACTG.
  • For what types of analyses? To achieve aims in the proposal approved by the ACTG.
  • By what mechanism will data be made available? Researchers may submit a request for access to data using the ACTG "Data Request" form at: https://actgnetwork.org/submit-a-proposal/. Researchers of approved proposals will need to sign an ACTG Data Use Agreement before receiving the data.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

결핵에 대한 임상 시험

Isoniazid에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Paraguay

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다