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

26. april 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

15

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Peking University People's Hospital
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Amphotericin B Treatment
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University People's Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. april 2026

Primær fullføring (Antatt)

1. desember 2028

Studiet fullført (Antatt)

31. desember 2028

Datoer for studieregistrering

Først innsendt

12. april 2026

Først innsendt som oppfylte QC-kriteriene

26. april 2026

Først lagt ut (Faktiske)

30. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. april 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PKUPH20260411

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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