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Et fase 1b/2-forsøg af bakteriofagterapiens sikkerhed og mikrobiologiske aktivitet hos patienter med cystisk fibrose koloniseret med Pseudomonas Aeruginosa

18. juni 2026 opdateret af: National Institute of Allergy and Infectious Diseases (NIAID)

Et fase 1b/2, multicentreret, randomiseret, dobbeltblindet, placebokontrolleret forsøg med sikkerhed og mikrobiologisk aktivitet af en enkelt dosis bakteriofagterapi hos patienter med cystisk fibrose koloniseret med Pseudomonas Aeruginosa

Dette er et fase 1b/2-studie af en enkelt dosis intravenøs (IV) bakteriofag hos mænd og ikke-gravide kvinder, mindst 18 år, diagnosticeret med cystisk fibrose (CF). Dette kliniske forsøg er designet til at vurdere sikkerheden og den mikrobiologiske aktivitet af bakteriofagproduktet WRAIR_PAM-CF1, rettet mod Pseudomonas aeruginosa i klinisk stabile CF-individer, der er kronisk koloniseret med P. aeruginosa. WRAIR_PAM-CF1 er en 4-komponent anti-pseudomonal bakteriofagblanding indeholdende mellem 4 x 10^7 og 4 x 10^9 Plaque Forming Units (PFU) af bakteriofag. Tilmelding vil ske på op til 20 kliniske steder i USA. I trin 1 vil to kvalificerede forsøgspersoner blive tildelt hver af de tre doseringsarme, der modtager en enkelt dosis af IV-bakteriofagterapien (4 x 10^7 PFU, 4 x 10^8 PFU og 4 x 10^9 PFU; i alt af 6 sentinel-personer), efterfulgt af 30 ± 7 dages observationsperiode. Hvis ingen SAE'er (relateret til undersøgelsesproduktet) identificeres i løbet af de 96 timer efter bakteriofagadministration for alle Sentinel-individer i trin 1, vil undersøgelsen fortsætte til trin 2. I trin 2a vil 32 forsøgspersoner blive indskrevet i en af ​​4 arme ( placebo IV, 4 x 10^7 PFU, 4 x 10^8 PFU og 4 x 10^9 PFU) i en 1:1:1:1 tildeling. En interimanalyse vil blive udført, efter at alle forsøgspersoner har gennemført opfølgningsbesøg 7 på dag 30 for at vælge den IV bakteriofagdosis med den mest gunstige sikkerheds- og mikrobiologiske aktivitetsprofil. Under trin 2b vil forsøgspersoner blive randomiseret til bakteriofagen (dosis valgt baseret på interimanalyse efter trin 2a) eller placebo-armen. Den endelige prøvestørrelse forventes at være op til 72 forsøgspersoner i alt med op til 25 forsøgspersoner i placebo-armen og op til 25 forsøgspersoner i fase 2b-bakteriofagdosis.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Dette er et fase 1b/2, multicenter, randomiseret placebokontrolleret dobbeltblindt studie af en enkelt dosis intravenøs (IV) bakteriofag hos mænd og ikke-gravide kvinder, mindst 18 år gamle, diagnosticeret med cystisk fibrose (CF). Dette kliniske forsøg er designet til at vurdere sikkerheden og den mikrobiologiske aktivitet af bakteriofagproduktet WRAIR_PAM-CF1, rettet mod P. aeruginosa i klinisk stabile CF-individer, der er kronisk koloniseret med P. aeruginosa. WRAIR_PAM-CF1 er en 4-komponent anti-pseudomonal bakteriofagblanding indeholdende mellem 4 x 10^7 og 4 x 10^9 Plaque Forming Units (PFU) af bakteriofag. Tilmelding vil ske på op til 20 kliniske steder i USA. I trin 1 vil to sentinel-personer blive tildelt hver af de tre doseringsarme, der modtager en enkelt dosis af IV-bakteriofagterapien (4 x 10^7 PFU, 4 x 10^8 PFU og 4 x 10^9 PFU; i alt af 6 sentinel-personer), efterfulgt af 30 ± 7 dages observationsperiode. Hvis ingen SAE'er (relateret til undersøgelsesproduktet) identificeres i løbet af de 96 timer efter bakteriofagadministration for alle Sentinel-individer i trin 1, vil undersøgelsen fortsætte til trin 2. I trin 2a vil 32 forsøgspersoner blive indskrevet i en af ​​4 arme ( placebo IV, 4 x 10^7 PFU, 4 x 10^8 PFU og 4 x 10^9 PFU) i en 1:1:1:1 tildeling. En interimanalyse vil blive udført, efter at alle forsøgspersoner har gennemført opfølgningsbesøg 7 på dag 30 for at vælge den IV bakteriofagdosis med den mest gunstige sikkerheds- og mikrobiologiske aktivitetsprofil. Under trin 2b vil forsøgspersoner blive randomiseret til bakteriofagen (dosis valgt baseret på interimanalyse efter trin 2a) eller placebo-armen. Den endelige prøvestørrelse forventes at være op til 72 forsøgspersoner i alt med op til 25 forsøgspersoner i placebo-armen og op til 25 forsøgspersoner i fase 2b-bakteriofagdosis. De primære formål med denne undersøgelse er at 1) beskrive sikkerheden ved en enkelt dosis IV bakteriofagterapi hos klinisk stabile CF-individer med P. aeruginosa i ekspektoreret sputum; 2) beskrive den mikrobiologiske aktivitet af en enkelt dosis IV bakteriofagterapi hos klinisk stabile CF-individer med P. aeruginosa i ekspektoreret sputum; 3) beskrive fordele-til-risiko-profilen ved en enkelt dosis IV bakteriofagbehandling hos klinisk stabile CF-personer med P. aeruginosa i ekspektoreret sputum.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

73

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85724-0001
        • The University of Arizona - Banner University Medical Center Tucson Campus - Tucson
    • California
      • La Jolla, California, Forenede Stater, 92037
        • University of California, San Diego
      • La Jolla, California, Forenede Stater, 92121
        • University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)
      • Los Angeles, California, Forenede Stater, 90095
        • University of California Los Angeles Medical Center - Westwood Clinic
      • Sacramento, California, Forenede Stater, 95816
        • University of California Davis Health
      • Stanford, California, Forenede Stater, 94305
        • Stanford University
    • Connecticut
      • North Haven, Connecticut, Forenede Stater, 06473
        • Yale North Haven Medical Center- Winchester Center for Lung Disease
    • Florida
      • Tampa, Florida, Forenede Stater, 22612
        • University of South Florida/Tampa General Hospital
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30324
        • Emory University - Adult Cystic Fibrosis Program
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21205
        • Johns Hopkins University
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • Michigan Medicine
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455-0341
        • University of Minnesota Medical Center
    • New York
      • New Hyde Park, New York, Forenede Stater, 11050
        • Northwell Health
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Western Reserve University
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, Forenede Stater, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, Forenede Stater, 77030-3411
        • Baylor College of Medicine
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia

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 til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

Forsøgspersoner skal opfylde alle inklusionskriterierne for at være berettiget til at deltage i undersøgelsen:

  1. Voksen (>/= 18 år) på screeningstidspunktet.

  2. Bekræftet CF-diagnose baseret på et kompatibelt klinisk syndrom bekræftet af enten en unormal svedkloridtest eller to CFTR-genvariationer.*

    *Kan fås fra dokumentation i journaler; faktiske testresultater er ikke nødvendige.

  3. Sandsynligvis i stand til at producere mindst 2 ml sputum under en 30-minutters sputumopsamling efter en hypertonisk saltvandsbehandling eller anden tilgang til at øge sputumproduktionen.*

    ** Bestemt af efterforskeren eller deres udpegede vurdering. Fremgangsmåder til opnåelse af sputum kan omfatte, men er ikke begrænset til, inhaleret hypertonisk saltvand (f.eks. 3 %, 7 % eller 10 %), inhaleret hypertonisk bicarbonat, inhaleret mannitol eller spontant ekspektoreret sputum. Den samme tilgang bør anvendes til alle sputumsamlinger for et givet emne.

  4. P. aeruginosa (uanset kolonidannende enheder (CFU)/ml) isoleret fra et sputum, halskultur eller anden luftvejsprøve inden for de seneste 12 måneder.
  5. Bekræftet P. aeruginosa-isolation fra en prøve af ekspektoreret sputum ved screeningsbesøget.
  6. I stand til at give informeret samtykke.
  7. I stand til og villig til at gennemføre alle studiebesøg og udføre alle procedurer, der kræves af protokollen.

Ekskluderingskriterier:

Forsøgspersoner, der opfylder nogen af ​​eksklusionskriterierne, vil ikke blive tilmeldt undersøgelsen:

  1. Kropsvægt < 30 kg.
  2. Forceret udåndingsvolumen 1 sekund < 20 % af den forudsagte værdi ved screening ved hjælp af Hankinson-ligningerne.

  3. Forhøjede LFT'er opnået ved screening.*

    *en. Alaninaminotransferase (ALT) > 5 x den øvre grænse for normal (ULN) eller aspartattransaminase (AST) > 5 x ULN eller total bilirubin > 3 x ULN, ELLER b. Total bilirubin > 1,5 x ULN kombineret med enten ALT > 3 x ULN eller AST > 3 x ULN. ULN afspejler lokale laboratorieområder.

  4. Akut klinisk sygdom, der kræver en ny (oral, parenteral) eller inhaleret antibiotika(r)

    *Inkluderer ikke kronisk undertrykkende medicin eller cyklisk doseringsmedicin såsom inhalationsantibiotika.

  5. Kvinder, der er gravide, planlægger at blive gravide i løbet af undersøgelsesperioden eller ammer.* *Kvinder i den fødedygtige alder skal have en negativ serum beta-human choriongonadotropintest under screening og acceptere at bruge en effektiv præventionsmetode i hele forsøgets varighed.*

    *En kvinde anses for at være den fødedygtige, medmindre den er postmenopausal eller kirurgisk steriliseret, og der er gået mindst 3 måneder siden steriliseringsproceduren.

    1. Kirurgiske steriliseringsprocedurer for kvinder omfatter tubal ligering, bilateral salpingektomi, hysterektomi eller bilateral oophorektomi.
    2. Kvinde anses for postmenopausal, hvis hun er >45 år gammel og har gået mindst 12 måneder uden en spontan menstruation uden anden kendt eller mistænkt årsag.
    3. Effektive præventionsmetoder omfatter (a) abstinens, (b) partnervasektomi, (c) intrauterine anordninger, (d) hormonimplantater (såsom Implanon), eller (e) andre hormonelle metoder (p-piller, injektioner, plastre, vaginale ringe).
  6. Aktiv behandling af enhver mykobakteriel eller svampeorganisme

  7. Forventet behov for at ændre kroniske antibiotikakure i løbet af undersøgelsesperioden.*

    *Forsøgspersoner på cyklisk doseringsmedicin såsom inhalationsantibiotika skal være i stand til og udtrykke vilje til at holde terapierne på screeningstidspunktet konstant (enten forblive i terapien eller ikke forblive i terapien) i varigheden af ​​opfølgningsperioden ( cirka 30 dage). Forsøgspersoner i kronisk suppressiv antimikrobiel terapi skal kunne og udtrykke vilje til at blive på terapierne i varigheden af ​​deres opfølgningsperiode. Dette inkluderer kronisk azithromycinbehandling.

  8. Kendt allergi over for enhver komponent i undersøgelsesproduktet.
  9. Ethvert væsentligt fund, der efter investigators mening ville gøre det usikkert for forsøgspersonen at deltage i denne undersøgelse.
  10. Tilmeldt et klinisk forsøg inden for
  11. I øjeblikket eller tidligere tilmeldt denne prøveperiode.

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: Sekventiel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Trin 2a Arm 1
25 ml 0,9 procent natriumchlorid-saltopløsning administreret intravenøst ​​i 30 minutter som en enkelt dosis. N=8
Andet: Placebo
0,9 procent natriumchlorid
Placebo komparator: Trin 2b Arm 1
25 ml 0,9 procent natriumchlorid-saltopløsning administreret intravenøst ​​i 30 minutter som en enkelt dosis. N=17
Andet: Placebo
0,9 procent natriumchlorid
Aktiv komparator: Trin 1/2a Arm 2
4x10^7 plakdannende enheder (PFU) af WRAIR-PAM-CF1 administreret intravenøst ​​med ca. 25 ml 0,9 procent natriumchlorid-saltopløsning i 30 minutter som en enkelt dosis. Trin 1: N=2 (vagtpostemner); Trin 2a: N=8
Biologisk: WRAIR-PAM-CF1
Bakteriofagkombination sammensat af følgende fager: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83 og PaWRA02Phi87.
Aktiv komparator: Trin 1/2a Arm 3
4x10^8 plakdannende enheder (PFU) af WRAIR-PAM-CF1 administreret intravenøst ​​med ca. 25 ml 0,9 procent natriumchlorid-saltopløsning i 30 minutter som en enkelt dosis. Trin 1: N=2 (vagtpostemner); Trin 2a: N=8
Biologisk: WRAIR-PAM-CF1
Bakteriofagkombination sammensat af følgende fager: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83 og PaWRA02Phi87.
Aktiv komparator: Trin 1/2a Arm 4
4x10^9 plakdannende enheder (PFU) af WRAIR-PAM-CF1 administreret intravenøst ​​med ca. 25 ml 0,9 procent natriumchlorid-saltopløsning i 30 minutter som en enkelt dosis. Trin 1: N=2 (vagtpostemner); Trin 2a: N=8
Biologisk: WRAIR-PAM-CF1
Bakteriofagkombination sammensat af følgende fager: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83 og PaWRA02Phi87.
Aktiv komparator: Trin 2b Arm 2
WRAIR-PAM-CF1-koncentration bestemt efter analyse efter trin 2a, administreret intravenøst ​​med 25 ml 0,9 procent natriumchlorid-saltopløsning i 30 minutter som en enkelt dosis. N=17
Biologisk: WRAIR-PAM-CF1
Bakteriofagkombination sammensat af følgende fager: PaWRA01Phi11, PaWRA01Phi39, PaWRA02Phi83 og PaWRA02Phi87.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants That Experienced Grade 2 or Higher Treatment-emergent Adverse Events in the ITT Population
Tidsramme: Day 1 through Day 30
An event that occurred during the treatment period was considered a treatment-emergent AE if it was not present before the first dose of investigational product or was present before the first dose of investigational product and increased in severity during the treatment period.
Day 1 through Day 30
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo in Stage 2a and 2b
Tidsramme: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are substituted with the limit of detection (LOD) of the assay (1 x 10^4 CFU/mL).
Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit in Stage 2a and 2b
Tidsramme: Day 1 Post-infusion, Day 2, Day 5, and Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10^4 CFU/mL)
Day 1 Post-infusion, Day 2, Day 5, and Day 8
Change From Baseline to Day 30 in log10 P. Aeruginosa Total Colony Counts in Quantitative Sputum Cultures After Administration of IV Bacteriophages/Placebo, Sensitivity Analysis for Stage 2a and 2b
Tidsramme: Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Mean change from baseline in log10-transformed counts of P. aeruginosa colony forming units per milliliter (CFU/mL) is presented for each time point through Day 30 as well as for each participant's minimum and maximum change from baseline. Undetectable colony counts are treated as missing.
Day 1 Post-infusion, Day 2, Day 5, Day 8, and Day 30
Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit, Sensitivity Analysis for Stage 2a and 2b
Tidsramme: Day 1 Post-infusion, Day 2, Day 5, and Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Day 1 Post-infusion, Day 2, Day 5, and Day 8
Number of Susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated by: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1 x 10^4 CFU/mL)
Baseline through Day 8
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).
Baseline through Day 8
Number of Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).
Baseline through Day 8
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8
A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8: Rank 1=No SAE (related to study product) and >2 log10 reduction in P. aeruginosa CFU/mL. Rank 2=No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL. Rank 3=No SAE (related to study product) and <1 log10 reduction in P. aeruginosa CFU/mL. Rank 4=SAE (related to study product). The DOOR probability is estimated using: Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are substituted with the LOD of the assay (1x10^4 CFU/mL).
Baseline through Day 8
Number of Susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8
Number of Non-susceptible to 4-bacteriophage Cocktail Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8
Number of Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8
Number of Not Co-colonized With Clinically Meaningful Organism Subgroup, Sensitivity Analysis Participants With Desirability of Outcome Ranking (DOOR) Probability Calculated Using the Greatest Reduction by Day 8 Follow-up Visit
Tidsramme: Baseline through Day 8

A DOOR rank is calculated for each participant based on the following ranking from most (rank 1) to least (rank 4) desirable outcome using each participant's greatest reduction from baseline in log10 P. aeruginosa CFU/mL by Day 8:

Rank 1 = No SAE (related to study product) and > 2 log10 reduction in P. aeruginosa CFU/mL.

Rank 2 = No SAE (related to study product) and 1-2 log10 reduction in P. aeruginosa CFU/mL.

Rank 3 = No SAE (related to study product) and < 1 log10 reduction in P. aeruginosa CFU/mL.

Rank 4 = SAE (related to study product).

The DOOR probability is estimated using:

Pr[DOOR]= Pr[DOORIV > DOORP] + 1/2Pr[DOORIV = DOORP] where DOORIV and DOORP are the DOOR ranks for bacteriophage (phage) and placebo arms, Pr[DOORIV > DOORP] is the proportion of DOOR ranks from IV phage dose exceeding DOOR ranks from placebo, and Pr[DOORIV = DOORP] is the proportion of phage and placebo DOOR ranks being the same. Undetectable colony counts are treated as missing.
Baseline through Day 8

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)

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.

Generelle publikationer

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)

3. oktober 2022

Primær færdiggørelse (Faktiske)

10. april 2025

Studieafslutning (Faktiske)

10. april 2025

Datoer for studieregistrering

Først indsendt

7. juli 2022

Først indsendt, der opfyldte QC-kriterier

7. juli 2022

Først opslået (Faktiske)

12. juli 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juli 2025

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20-0001
  • 2UM1AI104681-08 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

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 .

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