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

12. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

900

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Argentina
  • Austrálie
  • Botswana
      • Gaborone, Botswana
        • Gaborone CRS (Site #: 12701)
        • Kontakt:
      • Gaborone, Botswana
  • Brazílie
      • Rio Grande, Brazílie
        • Instituto de Pesquisas em AIDS do Rio Grande do Sul - IPARGS CRS (Site # 12201)
        • Kontakt:
      • Rio de Janeiro, Brazílie, 21040-360
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site #: 12101)
        • Kontakt:
  • Filipíny
    • Cavite
      • Dasmariñas, Cavite, Filipíny, 4114
        • TB HIV Innovations and Clinical Research Foundation Corp. (Site #: 31981)
        • Kontakt:
  • Haiti
      • Port-au-Prince, Haiti, HT-6110
        • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site #: 31730)
        • Kontakt:
      • Port-au-Prince, Haiti, HT-6110
        • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site #: 30022)
        • Kontakt:
  • Indie
      • Chennai, Indie
        • YRG CARE CRS (Site # 32075)
        • Kontakt:
    • Maharashtra
      • Pune, Maharashtra, Indie, 411001
        • Byramjee Jeejeebhoy Government Medical College (BJGMC) CRS (Site #: 31441)
        • Kontakt:
          • Nishi Suryavanshi, Ph.D.
          • Telefonní číslo: 91-98-23248979
          • E-mail: nsuryav1@jhmi.edu
  • Keňa
    • Rift Valley
      • Eldoret, Rift Valley, Keňa, 30100
        • Moi University Clinical Research Center (MUCRC) CRS (Site #: 12601)
        • Kontakt:
      • Kericho, Rift Valley, Keňa, 20200
        • Kenya Medical Research Institute/Walter Reed Project Clinical Research Center (KEMRI/WRP) CRS (Site #: 12501)
        • Kontakt:
  • Malawi
      • Blantyre, Malawi
        • Blantyre CRS (Site #: 30301)
        • Kontakt:
          • Dumisile Huwa
          • Telefonní číslo: 265-1811885
          • E-mail: dhuwa@jhp.mw
    • Central Region
      • Lilongwe, Central Region, Malawi
  • Mexiko
      • Mexico City, Mexiko, 14000
        • Nutrición-Mexico CRS (Site #: 32078)
        • Kontakt:
  • Peru
      • Callao, Peru
        • Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales CRS (CITBM) - Unidad de Ensayos Clínicos (UNIDEC) (Site # 31970)
        • Kontakt:
      • Lima, Peru
        • Barranco CRS (Site #: 11301)
        • Kontakt:
      • Lima, Peru
      • Lima, Peru
        • Socios en Salud Sucursal Peru CRS (Site # 31985)
        • Kontakt:
  • Tanzanie
      • Moshi, Tanzanie
        • Kilimanjaro Christian Medical Centre (KCMC) (Site # 5118)
        • Kontakt:
  • Thajsko
      • Bangkok, Thajsko
        • Siriraj Hospital, Mahidol University NICHD CRS (Site # 5115)
        • Kontakt:
      • Chiang Mai, Thajsko, 50200
        • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site #: 31784)
        • Kontakt:
          • Daralak Tavornprasit, R.N., M.Sc.
          • Telefonní číslo: 176 66-5-3936148
          • E-mail: daralak.t@cmu.ac.th
      • Chiang Rai, Thajsko
        • Chiangrai Prachanukroh Hospital NICHD CRS (Site # 5116)
        • Kontakt:
    • Bangkok
      • Pathum Wan, Bangkok, Thajsko, 10330
        • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site #: 31802)
        • Kontakt:
  • Uganda
      • Kampala, Uganda, 10005
        • Joint Clinical Research Centre (JCRC)/Kampala Clinical Research Site (Site #: 12401)
        • Kontakt:
          • Sandra Rwambuya, M.P.H.
          • Telefonní číslo: 256-772-779283
          • E-mail: dxr23@case.edu
      • Kampala, Uganda
        • MU-JHU Research Collaboration (MUJHU CARE LTD) CRS (Site # 30293)
        • Kontakt:
  • Vietnam
      • Hanoi, Vietnam, 100000
        • National Lung Hospital (Site #: 32483)
        • Kontakt:
  • Zimbabwe
      • Harare, Zimbabwe, 263663
        • Milton Park CRS (Site #: 30313)
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Rifampin
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Ethambutol
Administered orally once daily
Experimentální: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Rifapentine
Administered orally once daily
Lék: Moxifloxacin
Administered orally once daily
Aktivní komparátor: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Rifampin
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Ethambutol
Administered orally once daily
Experimentální: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Rifapentine
Administered orally once daily
Lék: Moxifloxacin
Administered orally once daily
Experimentální: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Rifapentine
Administered orally once daily
Lék: Moxifloxacin
Administered orally once daily
Experimentální: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Rifapentine
Administered orally once daily
Lék: Moxifloxacin
Administered orally once daily
Experimentální: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Rifapentine
Administered orally once daily
Lék: Moxifloxacin
Administered orally once daily
Experimentální: 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.
Lék: Isoniazid
Administered orally once daily
Lék: Pyrazinamide
Administered orally once daily
Lék: Rifapentine
Administered orally once daily
Lék: Moxifloxacin
Administered orally once daily

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Lower-risk group: Proportion of participants with sustained cure at 52 weeks after randomization
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Higher-risk group: Proportion of participants with sustained cure at 52 week after randomization
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Institute of Allergy and Infectious Diseases (NIAID)

Spolupracovníci

ViiV Healthcare

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

5. června 2026

Primární dokončení (Odhadovaný)

5. června 2029

Dokončení studie (Odhadovaný)

22. října 2029

Termíny zápisu do studia

První předloženo

6. května 2026

První předloženo, které splnilo kritéria kontroly kvality

12. května 2026

První zveřejněno (Aktuální)

19. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

19. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

12. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • A5414
  • 38987 (Jiný identifikátor: DAIDS-ES ID)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Časový rámec sdílení IPD

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.

Kritéria přístupu pro sdílení IPD

  • 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.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Sponzoři a spolupracovníci

Zdravotní podmínky

Drogové intervence

CROs by country

CROs in Uruguay

Podmínky

Vzácné nemoci

Drogové intervence

Doplňky stravy

Sponzor / Spolupracovníci

Místa

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