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Linezolid-doseringsstrategier ved lægemiddelresistent TB

28. april 2026 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Et fase II, prospektivt, randomiseret, multicenterforsøg til evaluering af effektiviteten og sikkerheden/tolerabiliteten af ​​to linezoliddoseringsstrategier i kombination med et kort kursus til behandling af lægemiddelresistent lungetuberkulose

Formålet med undersøgelsen er at evaluere effektiviteten (hvor godt medicinen virker) og tolerabiliteten (om deltagerne stopper behandlingen på grund af bivirkninger fra et lægemiddel eller behandling) af et anti-TB-behandlingsregime, der sammenligner to doser linezolid (LZD) , kombineret med bedaquilin (BDQ), delamanid (DLM) og clofazimin (CFZ). Denne undersøgelse vil også måle niveauet af disse lægemidler i deltagernes blod.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Der er i øjeblikket ingen "standard for pleje" eller enkelt standardiseret behandlingsregime, der anbefales til alle med lægemiddelresistent tuberkulose (DR-TB). Nuværende DR-TB-behandlinger tolereres muligvis ikke godt og kan ofte have bivirkninger. Der er behov for at identificere lægemidler med tilstrækkelig anti-TB-aktivitet (behandling mod TB) og gode sikkerhedsprofiler, som kan forbedre resultater i behandlingen af ​​DR-TB.

Hovedformålet med denne undersøgelse er at evaluere effektiviteten og tolerabiliteten af ​​et nyt kortere anti-TB-behandlingsregime, der sammenligner to doseringsstrategier linezolid (LZD), kombineret med bedaquilin (BDQ), delamanid (DLM) og clofazimin (CFZ) ). Som et sekundært mål vil undersøgelsen også vurdere sikkerheden (niveauet og typen af ​​bivirkninger fra et lægemiddel eller en behandling) ved kombinationen af ​​disse lægemidler.

Alle i undersøgelsen vil tage disse lægemidler en gang om dagen i hele behandlingsperioden: BDQ, DLM og CFZ. Forskellen mellem de to behandlingsgrupper i undersøgelsen er, hvordan deltagerne vil tage det fjerde lægemiddel: LZD. Deltagere i gruppe A vil tage én dosis LZD én gang dagligt i hele behandlingsperioden. Deltagerne i gruppe B vil tage en højere dosis LZD en gang dagligt i 4 uger og derefter fortsætte med at tage den højere dosis LZD kun tre gange om ugen i resten af ​​behandlingsperioden.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

138

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Botswana
    • South-East District
      • Gaborone, South-East District, Botswana
        • Gaborone CRS (Site ID: 12701)
  • Brasilien
      • Rio de Janeiro, Brasilien, 21040-360
        • Instituto de Pesquisa Clinica Evandro Chagas (IPEC) CRS (Site ID: 12101)
  • Filippinerne
      • Cavite, Filippinerne, 4114
        • De La Salle Health Science Institute Angelo King Medical Research Center (DLSHSI-AKMRC) (Site ID: 31981)
  • Haiti
      • Port-au-Prince, Haiti, HT-6110
        • GHESKIO Institute of Infectious Diseases and Reproductive Health (GHESKIO - IMIS) CRS (Site ID: 31730)
      • Port-au-Prince, Haiti, HT-6110
        • Les Centres GHESKIO Clinical Research Site (GHESKIO-INLR) CRS (Site ID: 30022)
  • Peru
      • Lima, Peru, 15063
        • Barranco CRS (Site ID: 11301)
  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2092
        • Wits Helen Joseph Hospital CRS (Wits HJH CRS) (Site ID: 11101)
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sydafrika, 4052
        • Durban International CRS (Site ID: 11201)
    • North West
      • Rustenburg, North West, Sydafrika, 0300
        • Rustenburg CRS (Site ID: 31684)
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7700
        • University of Cape Town Lung Institute (UCTLI) CRS (Site ID: 31792)
      • Cape Town, Western Cape, Sydafrika, 7705
        • South African Tuberculosis Vaccine Initiative (SATVI) CRS (Site ID: 31793)
  • Thailand
      • Chiang Mai, Thailand, 50200
        • Chiang Mai University HIV Treatment (CMU HIV Treatment) CRS (Site ID: 31784)
    • Bangkok
      • Pathum Wan, Bangkok, Thailand, 10330
        • Thai Red Cross AIDS Research Centre (TRC-ARC) CRS (Site ID: 31802)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Alder over eller lig med 18 år ved screening.
  2. Nydiagnosticeret pulmonal lægemiddelresistent tuberkulose (DR-TB), med resistens over for mindst rifampicin eller rifampin (som er et lægemiddel, der bruges til behandling af tuberkulose) bekræftet fra en opspytprøve, der er taget inden for 60 dage før indsejlingen.
  3. HIV-1 infektionsstatus dokumenteret som enten fraværende eller til stede.
  4. For deltagere, der lever med HIV, enten i øjeblikket på en antiretroviral terapi (ART)-kur eller villige og i stand til at starte ART inden for 30 dage efter indtræden.
  5. Efavirenz eller etravirin (lægemidler til behandling af HIV) skal seponeres, før en deltager begynder at tage anti-TB-medicin. For deltagere på efavirenz eller etravirin skal de være villige og i stand til at seponere disse mindst 7 dage før påbegyndelse af undersøgelses-TB-medicin.
  6. For deltagere, der lever med HIV, tæller CD4+-celler (en type hvide blodlegemer) større end eller lig med 50 celler/mm3 opnået inden for 60 dage før studiestart.
  7. For kvinder med reproduktionspotentiale, negativ serum- eller uringraviditetstest inden for 7 dage før indrejse.

  8. Kvinder med reproduktionspotentiale, som deltager i seksuel aktivitet, der kan føre til graviditet, skal acceptere at bruge to af følgende former for prævention, mens de modtager TB-undersøgelsesmedicin og i 30 dage efter at have stoppet undersøgelsesmedicinen:

    • Mandlige eller kvindelige kondomer
    • Diafragma eller cervikal hætte (med sæddræbende middel, hvis tilgængeligt)
    • Intrauterin enhed (IUD) eller intrauterin system (IUS)
    • Hormonbaseret prævention (f.eks. orale præventionsmidler, Depo-Provera, NuvaRing, implantater)
  9. Passende laboratorieværdier som bestemt af undersøgelseslægen opnået inden for 14 dage før indrejse.
  10. Karnofsky præstationsscore (et vurderingsværktøj til funktionsnedsættelse) større end eller lig med 50 inden for 30 dage før indrejse.
  11. Kandidatens og/eller værge/repræsentants evne og vilje til at give informeret samtykke og opfylde kravene til undersøgelsen.
  12. Røntgen af ​​thorax taget inden for 30 dage før indrejse.

Ekskluderingskriterier:

  1. Dokumentation for klinisk signifikante (som vurderet af undersøgelseslægen) aktive infektioner (herunder HIV-relaterede opportunistiske infektioner) andre end TB og HIV, der kræver behandling inden for 30 dage før indrejse.
  2. Bevis for klinisk signifikante (som vurderet af undersøgelseslægen) metaboliske, gastrointestinale, kardiovaskulære, muskuloskeletale, oftalmologiske, pulmonale, neurologiske, psykiatriske, endokrine sygdomme, malignitet eller andre abnormiteter (ud over den indikation, der undersøges), som ville interferere med undersøgelsesmedicin eller procedurer.
  3. Manglende evne til at tage oral medicin.
  4. Mistænkt eller dokumenteret TB, der involverer centralnervesystemet, klinisk signifikant nyre-TB eller TB-pericarditis, eller nuværende ekstrapulmonal TB, der involverer andre organsystemer, som kan interferere med undersøgelsesmedicin eller -procedurer, som vurderet af undersøgelseslægen.
  5. Forudgående behandling med et eller flere af undersøgelseslægemidlerne på noget tidligere tidspunkt for en episode af DR-TB, der ikke er den kvalificerende episode eller behandling i mere end 7 kumulative dage med et eller flere af undersøgelseslægemidlerne inden for 30 dage før tilmelding til kvalifikationsafsnittet af DR-TB.
  6. Anamnese med allergi eller overfølsomhed over for nogen af ​​undersøgelseslægemidlerne eller lægemidler i samme klasse som undersøgelseslægemidlerne.
  7. Kendt eller formodet aktuelt alkohol- og/eller stofmisbrug, der efter undersøgelseslægens mening er tilstrækkeligt til at kompromittere deltagerens sikkerhed og/eller samarbejde.
  8. Modtagelse af eventuelle forsøgslægemidler inden for 60 dage før indrejse.
  9. Kendt historie med forlænget QT-syndrom (hjerterytmetilstand, der potentielt kan forårsage hurtige, kaotiske hjerteslag) eller aktuelt forlænget QT-interval på screening-elektrokardiogram (en medicinsk test, der påviser hjerte- (hjerte) abnormiteter).
  10. Kendt historie med klinisk signifikant hjertearytmi (en tilstand, hvor hjertet slår med en uregelmæssig eller unormal rytme), der kræver medicin eller klinisk signifikant elektrokardiogram (EKG) abnormitet, efter undersøgelseslægens mening inden for 60 dage før indrejsen.
  11. Graviditet eller nuværende amning, eller intention om at blive gravid og/eller amme under undersøgelsesbehandling.
  12. Nuværende brug af monoaminoxidasehæmmere (type medicin, der bruges til at behandle depression) eller brug inden for 30 dage før indrejse.
  13. Nuværende brug af serotonerge midler inklusive SSRI/SNRI antidepressiva eller tidligere brug inden for 30 dage før indrejse.
  14. Kendt historie med optisk neuropati (skade på synsnerven i dit øje) af enhver grad som diagnosticeret af en øjenlæge.
  15. Aktuel perifer neuropati (når nerver er beskadigede eller ødelagte og ikke kan sende beskeder fra hjernen og rygmarven til musklerne, huden og andre dele af kroppen) med svære paræstesier ("nåle og nåle") og/eller mild svaghed eller værre (karakter ≥2.).
  16. Vægt mindre end 35 kg (77 lbs).
  17. Tager i øjeblikket anden forbudt medicin.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Arm A

Everyone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm A participants took linezolid (LZD) once a day for the entire treatment period.

  • Weeks 1-26: LZD 600 mg once daily (QD)
  • Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD
  • Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD
  • Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD
Medicin: Linezolid 600 mg
Én 600 mg tablet indtaget oralt én gang dagligt (QD) om morgenen i uge 1-26
Andre navne:
  • LZD
Medicin: Bedaquilin 200 mg
To 100 mg tabletter indtaget oralt en gang dagligt om morgenen i uge 1-8
Andre navne:
  • BDQ
Medicin: Bedaquilin 100 mg
Én 100 mg tablet indtaget oralt én gang dagligt om morgenen i uge 9-26
Andre navne:
  • BDQ
Medicin: Delamanid 300 mg
Seks 50 mg tabletter indtaget oralt én gang dagligt om morgenen i uge 1-26
Andre navne:
  • DLM
Medicin: Clofazimin 300 mg
Tre 100 mg kapsler indtaget oralt en gang dagligt om morgenen i uge 1-2
Andre navne:
  • CFZ
Medicin: Clofazimin 100 mg
En 100 mg kapsel taget oralt én gang dagligt om morgenen i uge 3-26
Andre navne:
  • CFZ
Eksperimentel: Arm B

Everyone in the study took bedaquiline (BDQ), delamanid (DLM), and clofazimine (CFZ) once a day for the entire treatment period. Arm B participants took a higher dose of linezolid (LZD) once a day for 4 weeks and then took that higher dose of LZD just three times a week for the rest of the treatment period.

  • Weeks 1-4: LZD 1200 mg once daily (QD)
  • Weeks 5-26: LZD 1200 mg three times per week (TIW)
  • Weeks 1-2: BDQ 200 mg QD + DLM 300 mg QD + CFZ 300 mg QD
  • Weeks 3-8: BDQ 200 mg QD + DLM 300 mg QD + CFZ 100 mg QD
  • Weeks 9-26: BDQ 100 mg QD + DLM 300 mg QD + CFZ 100 mg QD
Medicin: Bedaquilin 200 mg
To 100 mg tabletter indtaget oralt en gang dagligt om morgenen i uge 1-8
Andre navne:
  • BDQ
Medicin: Bedaquilin 100 mg
Én 100 mg tablet indtaget oralt én gang dagligt om morgenen i uge 9-26
Andre navne:
  • BDQ
Medicin: Delamanid 300 mg
Seks 50 mg tabletter indtaget oralt én gang dagligt om morgenen i uge 1-26
Andre navne:
  • DLM
Medicin: Clofazimin 300 mg
Tre 100 mg kapsler indtaget oralt en gang dagligt om morgenen i uge 1-2
Andre navne:
  • CFZ
Medicin: Clofazimin 100 mg
En 100 mg kapsel taget oralt én gang dagligt om morgenen i uge 3-26
Andre navne:
  • CFZ
Medicin: Linezolid 1200 mg (QD)
To 600 mg tabletter indtaget oralt én gang dagligt (QD) om morgenen i uge 1-4
Andre navne:
  • LZD
Medicin: Linezolid 1200 mg (TIW)
To 600 mg tabletter indtaget oralt tre gange om ugen (TIW; man-on-fre) om morgenen i uge 5-26
Andre navne:
  • LZD

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to 26 Weeks Stable Culture Conversion in Liquid Media
Tidsramme: Up to 26 weeks
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If the 1st MTB-neg liquid culture was at week 26, then conversion was met. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions at week 26 and the Cox proportional hazards regression model hazard ratio were calculated; between-arm differences were tested with the log rank test.
Up to 26 weeks
Proportion of Participants With Permanent Discontinuation of At Least One Anti-TB Drug Due To Adverse Events, Intolerance, Or Death
Tidsramme: Up to 26 weeks
Time of permanent discontinuation of at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue at least one anti-TB drug due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with at least one anti-TB drug or study visits, or due to participant request by week 26, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Up to 26 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants Achieving Stable Liquid Culture Conversion
Tidsramme: At week 8
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 8, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
At week 8
Proportion of Participants Achieving Stable Liquid Culture Conversion
Tidsramme: At week 16
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 16, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
At week 16
Proportion of Participants Achieving Stable Liquid Culture Conversion
Tidsramme: At week 26
Time of stable liquid culture conversion was the visit corresponding to the 1st of 2 consecutive MTB-neg cultures obtained at least 7 days apart without an intervening MTB-pos culture. Inability to produce sputum with or without induction was considered an MTB-neg culture. A participant was MTB-pos at a visit if at least 1 of the liquid cultures was MTB-pos. A participant was MTB-neg at a visit if both liquid cultures were MTB-neg or if 1 liquid culture was MTB-neg and the other was missing or indeterminate. If a participant did not convert by week 26, they were censored at their last culture result. If a participant died (any cause except trauma), they were censored at week 26 (worst possible outcome). Within-arm Kaplan-Meier estimates of proportions of participants with stable liquid culture conversion were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
At week 26
Proportion of Participants Achieving Stable Liquid Culture Conversion
Tidsramme: At week 38
The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 38 visit will be analyzed after the study completion date.
At week 38
Proportion of Participants With Permanent Discontinuation of LZD Due To Adverse Events, Intolerance, or Death
Tidsramme: Up to 26 weeks
Time of permanent discontinuation of LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request was the corresponding date of discontinuation. If a participant did not permanently discontinue LZD due to side effects that did not lead to a protocol-required discontinuation, due to participant non-compliance with LZD or study visits, or due to participant request by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with permanent discontinuation were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Up to 26 weeks
Proportion of Participants With Temporary Discontinuation of LZD For Any Reason
Tidsramme: Up to 26 weeks
Time of temporary discontinuation of LZD for any reason was the corresponding date of first temporary discontinuation. If a participant did not temporarily discontinue LZD by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with temporary discontinuation of LZD were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Up to 26 weeks
Proportion of Participants With LZD Dose Reduction
Tidsramme: Up to 26 weeks
Time of LZD dose reduction was the corresponding date of the first LZD dose reduction. If a participant did not undergo a LZD dose reduction by week 26, they were censored at the date of permanent discontinuation of LZD or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with LZD dose reduction were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Up to 26 weeks
Proportion of Participants With Treatment-Related Adverse Events
Tidsramme: Up to 26 weeks
Time of treatment-related adverse event was the corresponding date of the averse event. If a participant did not experience a treatment-related adverse event, they were censored at the date of permanent treatment discontinuation of all study drugs or, if still on study treatment, at week 26. Within-arm Kaplan-Meier estimates of proportions of participants with treatment-related adverse event were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
Up to 26 weeks
Proportion of Participants With Unfavorable TB Treatment Outcome
Tidsramme: At week 26
Unfavorable TB treatment outcome is defined as meeting one or more of the following: 1. Participants with confirmed microbiologic TB treatment failure; 2. Participants who fail to complete study treatment or require extension of study treatment beyond the study-prescribed treatment duration due to clinically inadequate response; 3. Participants who had a positive sputum MTB culture at their last study visit; 4. Participants who die from any cause during study treatment, except from violent or accidental cause; or 5. Participants failing to complete study treatment and not assessable at the end of the follow-up period. If a participant did not experience an unfavorable TB treatment outcome by week 26, they were censored at their last TB treatment outcome determination. Within-arm Kaplan-Meier estimates of proportions of participants with unfavorable TB treatment outcome were calculated with 2-sided 95% confidence intervals using standard errors based on Greenwood's formula.
At week 26
Proportion of Participants With Unfavorable TB Treatment Outcome
Tidsramme: At week 38
The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 38 visit will be analyzed after the study completion date.
At week 38
Proportion of Participants With Unfavorable TB Treatment Outcome
Tidsramme: At week 72
The study's primary completion date corresponded to the week 26 visit. Thus, data only through week 26 were analyzed. Data from the week 72 visit will be analyzed after the study completion date.
At week 72
Pharmacokinetic Parameter for Linezolid: Minimum Plasma Concentration (Cmin)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Linezolid: Maximum Plasma Concentration (Cmax)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Linezolid: Time to Reach Maximum Plasma Concentration (Tmax)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Linezolid: Area Under the Concentration-time Curve (AUC)
Tidsramme: At week 4
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
At week 4
Pharmacokinetic Parameter for Linezolid: Apparent Oral Clearance (CL/F)
Tidsramme: At week 4
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
At week 4
Pharmacokinetic Parameter for Delamanid: Minimum Plasma Concentration (Cmin)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Delamanid: Maximum Plasma Concentration (Cmax)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Delamanid: Time to Reach Maximum Plasma Concentration (Tmax)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Delamanid: Area Under the Concentration-time Curve (AUC)
Tidsramme: At week 4
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
At week 4
Pharmacokinetic Parameter for Delamanid: Apparent Oral Clearance (CL/F)
Tidsramme: At week 4
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Minimum Plasma Concentration (Cmin)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Maximum Plasma Concentration (Cmax)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Time to Reach Maximum Plasma Concentration (Tmax)
Tidsramme: At week 4
Estimated based on concentrations from intensive PK sampling times at pre-dose, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours.
At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Area Under the Concentration-time Curve (AUC)
Tidsramme: At week 4
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA). AUC24h (area under the curve from 0 to 24 hours) were determined using the linear-log trapezoidal rule.
At week 4
Pharmacokinetic Parameter for Delamanid Metabolite (DM-6705): Apparent Oral Clearance (CL/F)
Tidsramme: At week 4
Pharmacokinetic parameters were determined from plasma concentration-time profiles using noncompartmental methods (WinNonlin version 4.01, Pharsight Corp., Mountain View, CA).
At week 4
Number of Participants With >90% Directly Observed Therapy Doses Taken During the Treatment Period
Tidsramme: Up to 26 weeks
At each visit, the site reported the number of directly observed therapy (DOT) doses since the last visit. The number of expected DOT doses was 182. The number of expected DOT doses was adjusted by removing the number of days during temporary holds due to adverse events. This avoided penalizing participants who missed DOT doses due to protocol-required treatment holds for adverse events. Participants who missed DOT doses for other reasons were penalized even if they made up the missed doses by the week 30 study visit as allowed by the protocol. The proportion of expected 182 DOT doses was calculated as the total number of DOT doses reported by the site divided by the adjusted number of expected DOT doses.
Up to 26 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Samarbejdspartnere

Pfizer
Otsuka Pharmaceutical Development & Commercialization, Inc.

Efterforskere

  • Studiestol: Constance A. Benson, The University of California, San Diego

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

27. september 2022

Primær færdiggørelse (Faktiske)

14. marts 2025

Studieafslutning (Faktiske)

13. januar 2026

Datoer for studieregistrering

Først indsendt

22. juli 2021

Først indsendt, der opfyldte QC-kriterier

9. august 2021

Først opslået (Faktiske)

16. august 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A5356

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Individuelle deltagerdata, der ligger til grund, resulterer i offentliggørelsen efter afidentifikation.

IPD-delingstidsramme

Begyndende 3 måneder efter offentliggørelsen og tilgængelig i hele perioden for finansiering af AIDS Clinical Trials Group af NIH.

IPD-delingsadgangskriterier

  • Med hvem? Forskere, der giver et metodisk forsvarligt forslag til brug af data, der er godkendt af AIDS Clinical Trials Group.
  • Til hvilke typer analyser? At nå målene i forslaget godkendt af AIDS Clinical Trials Group.
  • Ved hvilken mekanisme vil data blive gjort tilgængelige? Forskere kan indsende en anmodning om adgang til data ved hjælp af AIDS Clinical Trials Group "Data Request"-formularen på: https://actgnetwork.org/submit-a-proposal/. Forskere af godkendte forslag skal underskrive en AIDS Clinical Trials Group Data Use Agreement, før de modtager dataene.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner