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A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological Malignancy

2. maj 2019 opdateret af: Xian-Janssen Pharmaceutical Ltd.

A Multicenter, Randomized Trial Comparing The Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Subjects With Hematological Malignancy

The purpose of this study is to investigate the hypothesis that the efficacy of intravenous (IV) itraconazole followed by oral itraconazole is non-inferior to that of intravenous caspofungin as empiric therapy for suspected fungal infection participants with fever and neutropenia.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

61

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

  • Kina
      • Beijign, Kina
      • Beijing, Kina
      • Changchun, Kina
      • Changzhou, Kina
      • Fuzhou, Kina
      • Guangzhou, Kina
      • Guiyang, Kina
      • Hefei, Kina
      • Shanghai, Kina
      • Suzhou, Kina
      • Tianjin, Kina
      • Zhengzhou, Kina

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

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participant must be hospitalized with hematologic malignancy treated by myelosuppressive therapy and/or Hematopoietic stem cell transplantation
  • Participant must have a diagnosis of neutropenia with neutrophil count < 500/microliters (mcL) (0.5 × 10^9/ liters [L]) for at least 96 hours at screening
  • Participant must have a diagnosis of fever and meet the following criteria: 1) Oral/rectal temperature greater than or equal to (>=) 38 degree celsius or axillary temperature (>=) 37.5 degree celsius and is not considered related to blood products transfusion or drug fever, 2) Not responding to broad-spectrum gram-positive and gram-negative antibiotics for 4-7 days with or without signs and symptoms that potentially attributable to deep fungal infection and 3) Defervescence within 3 days after the first broad-spectrum antibiotics but recurrence afterwards.
  • A woman of childbearing potential must have a negative serum (beta human chorionic gonadotropin [b hCG]) and pregnancy test at screening
  • A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study period and until the menstrual period following the end of study treatment

Exclusion Criteria:

  • Is concomitantly using other systematic antifungal drugs as empirical treatment
  • Has evidence of inadequately managed bacterial infection
  • Is currently receiving any Cytochrome P450 3A4 (CYP3A4)-metabolized/P-glycoprotein-transported drugs (including but not limited to cisapride, pimozide, quinidine, dofetilide, levacetylmethadol, terfenadine, astemizole, mizolastine, bepridil, sertindole, 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase (HMG-CoA reductase) inhibitor [for example, simvastatin, lovastatin], oral midazolam, triazolam, ergot alkaloids [eg, dihydroergotamine, ergonovine, ergotamine, methylergonovine] and nisoldipine) that should be prohibited in this study
  • Has known allergy, intolerance or hypersensitivity to azole and echinocandin antifungals or its excipients
  • Has a contraindication to the use of sodium chloride injection

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: Itraconazol
Medicin: Itraconazole
Participants will receive 200 milligram (mg) of itraconazole intravenously (IV) twice daily on Day 1 and Day 2, followed by 200 mg once daily through Day 14. From Day 15 to Day 28, participants will receive 200 mg (20 milliliters [mL]) of itraconazole oral solution orally twice daily. Participants, who are not suitable for oral administration of itraconazole based on the investigator's judgment, will receive 200 mg of itaconazole IV once daily from Day 15 to Day 28.
Aktiv komparator: Caspofungin
Medicin: Caspofungin
Participants will receive 70 mg of caspofungin IV once daily on Day 1 followed by 50 mg IV infusion once daily thereafter through Day 28.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints
Tidsramme: Up to 36 days
Response rate in each of the 2 treatment groups will be measured by the percentage of participants that achieve all of the following 5 composite endpoints: 1) survival for 7 days after completion of treatment, 2) absence of breakthrough invasive fungal infection during the study drug administration and within the first 7 days after completion of treatment, 3) successful treatment of baseline fungal infection, 4) defervescence and 5) no premature withdrawal from the study due to drug-related toxicity or lack of efficacy.
Up to 36 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Survival for 7 Days After Completion of Treatment
Tidsramme: Up to 36 days
Up to 36 days
Percentage of Participants With Absence of Breakthrough Invasive Fungal Infection
Tidsramme: Day 3 up to Day 28 (End of treatment [EoT]) and within 7 days after EoT (Day 29 up to Day 35)
Absence of breakthrough invasive fungal infection is defined as the clinically or/and microbiologically documented fungal infection with an onset on or after day 3 of the study treatment during the study drug administration and within the first 7 days after completion of treatment.
Day 3 up to Day 28 (End of treatment [EoT]) and within 7 days after EoT (Day 29 up to Day 35)
Percentage of Participants With Successful Treatment of Baseline Fungal Infection
Tidsramme: Screening up to Day 3
Successful treatment of baseline fungal infection is defined as the clinically and microbiologically documented fungal infection with an onset within screening to 2 days after the study treatment.
Screening up to Day 3
Percentage of Participants With Defervescence During the Period of Neutropenia
Tidsramme: Up to 36 days
Defervescence is defined as oral/rectal temperature less than (<) 38 degree celsius or axillary temperature (<) 37.5 degree celsius for over 48 hours) during the period of neutropenia.
Up to 36 days
Percentage of Participants With No Premature Withdrawal From the Study due to Drug-related Toxicity or Lack of Efficacy
Tidsramme: Up to 36 days
Up to 36 days
Response Rate Measured by the Percentage of Participants That Achieve all of the Following 5 Composite Endpoints With Oral Administration of Itraconazole
Tidsramme: Up to 36 days
Response rate will be measured by the percentage of participants (who received oral administration of itraconazole) that achieve all of the following 5 composite endpoints: 1) survival for 7 days after completion of treatment, 2) absence of breakthrough invasive fungal infection during the study drug administration and within the first 7 days after completion of treatment, 3) successful treatment of baseline fungal infection, 4) defervescence and 5) no premature withdrawal from the study due to drug-related toxicity or lack of efficacy.
Up to 36 days

Samarbejdspartnere og efterforskere

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

Sponsor

Xian-Janssen Pharmaceutical Ltd.

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)

30. november 2016

Primær færdiggørelse (Faktiske)

2. maj 2018

Studieafslutning (Faktiske)

2. maj 2018

Datoer for studieregistrering

Først indsendt

6. september 2016

Først indsendt, der opfyldte QC-kriterier

6. september 2016

Først opslået (Skøn)

9. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. maj 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CR108202
  • R051211FUN4057 (Anden identifikator: Xian-Janssen Pharmaceutical Ltd., China)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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