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Amphotericin B for Breakthrough Fungal Infections After Triazole Prophylaxis in Hematological Patients

26. april 2026 opdateret af: Xiao-Jun Huang, Peking University People's Hospital

A Multicenter, Prospective, Observational Study to Evaluate the Efficacy and Safety of Amphotericin B in the Treatment of Breakthrough Invasive Fungal Disease in Hematological Patients Receiving Triazole Prophylaxis

The goal of this clinical trial is to learn if amphotericin B works to treat breakthrough invasive fungal disease (IFD) in patients with hematological diseases who have received azole-based prophylaxis. It will also learn about the safety of amphotericin B in this population.

The main questions it aims to answer are:

  1. What is the overall response rate (complete remission + partial remission) of amphotericin B in treating breakthrough IFD after azole prophylaxis?
  2. What medical problems do participants have when taking amphotericin B?
  3. What is the 6-week (42-day) overall survival rate after starting treatment?

This is a single-arm, prospective study. Participants will:

  1. Receive intravenous liposomal amphotericin B (3-5 mg/kg daily) for 4-6 weeks.
  2. Undergo weekly clinical and laboratory assessments, including serum G/GM tests, microbiology tests, and imaging (CT) at 2, 4, and 6 weeks.
  3. Have safety monitoring including liver and kidney function, electrolytes, and ECG.
  4. Be followed for treatment response and survival.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Peking University People's Hospital
        • Kontakt:

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

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age ≥ 18 years old.
  2. Diagnosed with hematological diseases and receiving triazole prophylaxis.
  3. Confirmed or suspected breakthrough invasive fungal disease (IFD) according to EORTC/MSG 2020 criteria.
  4. Able to understand and sign the informed consent form voluntarily.

Exclusion Criteria:

  1. Severe liver or renal dysfunction (ALT/AST > 3×ULN, Cr > 2×ULN).
  2. Known allergy to amphotericin B or any component of the study drug.
  3. Pregnant or lactating women.
  4. Severe underlying diseases with expected survival < 3 months.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Amphotericin B Treatment
Medicin: Amphotericin B
Amphotericin B is a polyene antifungal drug used to treat breakthrough fungal infections. The dosage and duration will be determined based on pathogen results and clinical guidelines.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Response Rate of Antifungal Therapy at 6 Weeks (42 Days)
Tidsramme: 6 weeks (42 days) after treatment initiation
The overall response rate will be assessed at 6 weeks (42 days) after the initiation of amphotericin B treatment, evaluated according to the EORTC/MSG 2020 criteria for invasive fungal disease, including complete response, partial response, stable disease, and progressive disease.
6 weeks (42 days) after treatment initiation

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival Rate at 6 Weeks
Tidsramme: 6 weeks (42 days) after treatment initiation
Proportion of participants alive at 6 weeks (42 days) after initiation of amphotericin B therapy.
6 weeks (42 days) after treatment initiation
Change in serum G test level
Tidsramme: From enrollment to the end of 6-week treatment
Change from baseline in serum (1,3)-β-D-glucan level. Unit of measure: pg/mL.
From enrollment to the end of 6-week treatment
Change in serum GM test level
Tidsramme: From enrollment to the end of 6-week treatment
Change from baseline in serum galactomannan test value. Unit of measure: ug/L.
From enrollment to the end of 6-week treatment
Microbiological clearance
Tidsramme: From enrollment to the end of 6-week treatment
Proportion of participants with negative conversion of baseline positive microbiological evidence (e.g., blood culture, sputum culture, mNGS, or site smear/culture).
From enrollment to the end of 6-week treatment
Change in chest CT findings
Tidsramme: Baseline to 6 weeks after treatment initiation
Change from baseline in chest CT lesion characteristics (e.g., reduction in size, new lesions, complete resolution).
Baseline to 6 weeks after treatment initiation
Proportion of participants with treatment-emergent adverse events (AEs)
Tidsramme: From first dose to 30 days after last dose.
Proportion of participants experiencing any AE, graded according to WHO toxicity criteria (grade 3 or higher AEs leading to drug discontinuation).
From first dose to 30 days after last dose.
Proportion of participants discontinuing amphotericin B due to adverse events
Tidsramme: During treatment period (up to 6 weeks).
Proportion of participants who permanently stop amphotericin B because of any AE.
During treatment period (up to 6 weeks).
Change in serum alanine aminotransferase (ALT)
Tidsramme: Baseline to end of treatment up to 6 weeks (twice weekly).
Change from baseline in ALT level. Unit of measure: U/L.
Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum aspartate aminotransferase (AST)
Tidsramme: Baseline to end of treatment up to 6 weeks (twice weekly).
Change from baseline in AST level. Unit of measure: U/L.
Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum total bilirubin
Tidsramme: Baseline to end of treatment up to 6 weeks (twice weekly).
Change from baseline in total bilirubin level. Unit of measure: μmol/L.
Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum creatinine
Tidsramme: Baseline to end of treatment up to 6 weeks (twice weekly).
Description: Change from baseline in serum creatinine level. Unit of measure: μmol/L.
Baseline to end of treatment up to 6 weeks (twice weekly).
Change in serum electrolyte levels (potassium, sodium, calcium, magnesium)
Tidsramme: Baseline to end of treatment up to 6 weeks (twice weekly).
Change from baseline in serum levels of potassium, sodium, calcium, and magnesium. Each electrolyte will be reported separately as absolute change (mmol/L) from baseline.
Baseline to end of treatment up to 6 weeks (twice weekly).
Change in electrocardiogram (ECG) findings
Tidsramme: Baseline to end of treatment up to 6 weeks (weekly).
Change from baseline in ECG parameters (e.g., QTc interval).
Baseline to end of treatment up to 6 weeks (weekly).

Samarbejdspartnere og efterforskere

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

Sponsor

Peking University People's Hospital

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 (Anslået)

1. april 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

31. december 2028

Datoer for studieregistrering

Først indsendt

12. april 2026

Først indsendt, der opfyldte QC-kriterier

26. april 2026

Først opslået (Faktiske)

30. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. april 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PKUPH20260411

Plan for individuelle deltagerdata (IPD)

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INGEN

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