Europas førende søgning efter kliniske forsøg

Amphotericin B

Clinical trials are studying Amphotericin B in several patient groups, including people with fungal lung infections, esophageal cancer, kidney transplant recipients, patients with invasive mold infections, and people with inflammatory bowel disease. These studies mainly look at safety, where the treatment goes in the body, and how well it may help prevent or treat infection.

Table of contents

Trial overview

The trial data show several interventional studies that include Amphotericin B in different ways, such as oral use, inhalation, endotracheopulmonary use, and intravenous administration.[1][2][3][4][5][6] The studies are in Phase 1, Phase 2, Phase 3, and Low Intervention designs, which means they range from early testing to larger studies of effect.[1][2][3][4][5][6] The planned enrollment ranges from 18 to 853 participants.[1][2][3][4][5][6]

These trials do not study Amphotericin B for one single disease.[1][2][3][4][5][6] Instead, they look at infection-related questions in fungal disease, surgery, transplant care, and immune system research.[1][2][3][4][5][6]

Lung fungal infections

Two trials focus on fungal disease in the lungs.[3][5] The NIMBUS study is a Phase 1 study in people with chronic pulmonary aspergillosis, which is a long-lasting fungal infection in the lungs caused by Aspergillus.[3] It studies inhaled liposomal Amphotericin B, also called AmBisome, and uses Technetium-99m labelled AmBisome to see where the drug goes in the lungs.[3]

The main goals in NIMBUS are to measure how much AmBisome is deposited in the lungs by SPECT/CT, to compare lung levels with blood concentrations, and to help choose the best dose of nebulised treatment.[3] This means the study is not only asking whether the drug reaches the lungs, but also how it spreads and how much enters the blood.[3]

A second lung study is a Phase 2, monocentric, prospective, nonrandomized, open-label trial in people with simple aspergilloma.[5] It tests intrabronchial instillation of liposomal Amphotericin B, which means the medicine is placed into the airways through the bronchi.[5] The main outcome is the relative change in lesion size, meaning the study checks whether the fungal mass becomes smaller after treatment.[5]

Infection prevention and surgery

One large Low Intervention trial studies people with primary resectable esophageal carcinoma, which is a type of esophageal cancer that can be removed by surgery.[2] In this study, Amphotericin B is part of a selective decontamination of the digestive tract, often shortened to SDD.[2] SDD means using oral agents to reduce harmful germs in the digestive tract before and around surgery.[2]

The trial aims to prevent severe infectious complications after esophagectomy, especially postoperative pneumonia.[2] It includes a large enrollment of 853 participants and measures the cumulative incidence of pneumonia within 30 days after surgery.[2] Pneumonia is defined in the study by sputum culture results or by a new lung infiltrate plus clinical signs such as fever, abnormal white blood cell count, or purulent secretions.[2]

Gut microbiota and immune cells

Another Phase 2 study looks at the gut microbiota, which means the community of bacteria and other microorganisms living in the intestine.[1] The trial includes healthy adults with no history of gastrointestinal disease and patients with inflammatory bowel disease in remission.[1] It uses oral Amphotericin B together with vancomycin and gentamicin_APHP.[1]

The study wants to understand how the gut microbiota, and changes to it in inflammatory bowel disease, affect the energy metabolism of peripheral immune cells.[1] The main outcome is energy metabolism in major immune cell types from a blood sample, measured with single-cell energetic metabolism profiling and translation inhibition profiling.[1] In simple words, the researchers are studying how immune cells use energy and whether that changes when the gut bacteria are altered.[1]

Transplant and blood cancer studies

One Phase 1 study in kidney transplant recipients includes Ampho-Moronal as part of the background treatment while testing Treg02, which is a regulatory T-cell therapy.[4] The study population is people receiving a kidney transplant from a deceased donor.[4] The main purpose is to assess safety and tolerability of the cell therapy as an extra treatment alongside standard immunosuppressive therapy.[4]

This transplant study measures several safety outcomes, including acute toxicity, over-suppression of the immune system, chronic toxicity, and biopsy-confirmed acute rejection within 60 weeks after transplant.[4] Although Ampho-Moronal is listed with the study medicines, the trial focus is on the cell therapy and transplant safety rather than on Amphotericin B alone.[4]

A different Phase 2 study in very high-risk T-lineage acute lymphoblastic leukemia, or very high-risk T-ALL, includes Amphotericin B among many supportive medicines given with daratumumab and chemotherapy.[6] The trial aims to improve MRD-negativity, which means no measurable residual disease after induction treatment.[6] The primary endpoint is clinical response after the first induction cycle, measured as MRD negativity below 10^-4.[6]

What outcomes are measured

The outcomes in these trials reflect the different research questions being asked.[1][2][3][4][5][6] In the lung studies, researchers measure drug deposition in the lungs, blood levels, and change in lesion size.[3][5] In the surgery study, the key outcome is pneumonia within 30 days after esophagectomy.[2]

In the immune and transplant studies, the endpoints include immune cell energy metabolism, safety, toxicity, and acute rejection after transplant.[1][4] In the leukemia study, the main result is whether the patient becomes MRD-negative after induction treatment.[6] Together, these endpoints show that Amphotericin B is being studied in very different clinical settings, from infection prevention to lung delivery and immune-related research.[1][2][3][4][5][6]

Trial ID Phase Condition studied Status Enrollment
2025-521770-34-00 Phase 1 Chronic pulmonary aspergillosis Authorised 18
2025-523501-15-00 Phase 2 Simple aspergilloma Authorised 20
2024-516216-16-00 Phase 3 Invasive mold infections Authorised 210
NCT05865743 Low Intervention Esophageal cancer Authorised 853
2024-513330-38-00 Phase 2 Healthy adults; inflammatory bowel disease in remission Authorised 45
2024-514398-23-00 Phase 1 Kidney transplant recipients Authorised 27
NCT06253637 Phase 2 Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) Authorised 31

FAQ

  • Who is being studied in trials with Amphotericin B? The trials include healthy adults, patients with inflammatory bowel disease in remission, people with esophageal cancer, patients with chronic pulmonary aspergillosis or simple aspergilloma, adult patients with invasive mold infections, and kidney transplant recipients.
  • What are the trials trying to find out? They are looking at several things, such as infection prevention, treatment effect, how the drug is distributed in the lungs, and how the gut microbiota may affect energy metabolism in immune cells.
  • What phases are these Amphotericin B trials in? The trials include Phase 1, Phase 2, Phase 3, and Low Intervention studies. This shows that some trials are early and focus on safety or drug distribution, while others test effectiveness in larger patient groups.
  • Which conditions are being studied? The conditions include chronic pulmonary aspergillosis, simple aspergilloma, invasive mold infections, esophageal cancer, inflammatory bowel disease, and kidney transplantation.
  • What kinds of results are being measured? The trials measure outcomes such as lung deposition of the drug, postoperative pneumonia, lesion size, day 42 death rate, acute rejection after kidney transplant, and energy metabolism in immune cells.

Igangværende kliniske forsøg for Amphotericin B

  • Undersøgelse af regulatoriske T-celler (Treg02) som supplerende behandling hos nyretransplanterede patienter for at vurdere sikkerhed og tolerance

    Rekrutterer

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tyskland

  • Undersøgelse af fosmanogepix til behandling af voksne patienter med invasive skimmelsvampeinfektioner forårsaget af Aspergillus, Fusarium, Lomentospora prolificans og andre multiresistente skimmelsvampe

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Østrig Belgien Frankrig Tyskland Grækenland Italien +2

  • Undersøgelse af hvordan tarmbakterier påvirker kroppens energi hos raske personer og patienter med inflammatorisk tarmsygdom (IBD)

    Rekrutterer

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

  • Kan tarmrensning før operation mindske risikoen for alvorlige infektioner hos patienter med kræft i spiserøret?

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Belgien Holland

  • Undersøgelse af effekten og sikkerheden ved brug af liposomal amphotericin B til behandling af patienter med simpel lungeaspergillom

    Rekrutterer endnu ikke

    1 1 1
    Undersøgte lægemidler:
    Letland

  • Undersøgelse af inhaleret liposomal amphotericin B og technetium-99m til patienter med kronisk pulmonal aspergillose for at vurdere fordelingen af lægemidlet i lungerne

    Rekrutterer endnu ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Holland

  • Test af lægemidlet daratumumab til voksne med høj-risiko T-celle akut leukæmi

    Rekrutterer ikke

    1 1 1
    Undersøgte lægemidler:
    Italien

Ordliste

  • Klinisk forsøg: En forskningsundersøgelse i mennesker, hvor man tester en behandling eller en strategi for at se, om den er sikker og virker.
  • Interventionelt studie: Et forsøg, hvor deltagerne får en aktiv behandling eller sammenligningsbehandling, så forskerne kan måle effekten.
  • Fase 1: En tidlig forsøgsfase, hvor man ofte ser på sikkerhed og hvordan behandlingen opfører sig i kroppen.
  • Fase 2: En forsøgsfase, hvor man undersøger både sikkerhed og om behandlingen ser ud til at virke.
  • Fase 3: En større forsøgsfase, hvor en behandling sammenlignes med andre muligheder for at vurdere effekt og sikkerhed.
  • Low Intervention: Et studie med lavere grad af indgreb, ofte med fokus på observation eller mindre omfattende behandling.
  • Primært endepunkt: Det vigtigste resultat, som forskerne har valgt at måle i forsøget.
  • Enrolment: Antal deltagere, som forsøget planlægger at inkludere.
  • Pulmonal deposition: Hvor meget af en inhaleret behandling der faktisk aflejres i lungerne.
  • MRD-negativitet: At der ikke kan påvises målbar restsygdom, altså meget små rester af sygdom efter behandling.
  • Akut afstødning: Når kroppen hurtigt reagerer mod et transplanteret organ.
  • Pneumoni: Lungebetændelse, altså en infektion i lungerne.

Referencer

  1. https://clinicaltrials.gov/study/2024-513330-38-00
  2. https://kliniske-forsoeg.dk/forsog/kan-tarmrensning-for-operation-mindske-risikoen-for-alvorlige-infektioner-hos-patienter-med-kraeft-i-spiseroret/
  3. https://clinicaltrials.gov/study/2025-521770-34-00
  4. https://clinicaltrials.gov/study/2024-514398-23-00
  5. https://clinicaltrials.gov/study/2025-523501-15-00
  6. https://kliniske-forsoeg.dk/forsog/test-af-laegemidlet-daratumumab-til-voksne-med-hoj-risiko-t-celle-akut-leukaemi/