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Not yet recruitingRare disease

Efficacy of isavuconazonium sulfate and amphotericin B drug combination for initial treatment of mucormycosis in adults

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study examines adults with mucormycosis, a rare fungal infection that can involve the sinuses, brain, or lungs. Participants receive a combination of two antifungal medicines: oral or infusion form of isavuconazole (code name ISZ) and intermittent high‑dose liposomal amphotericin B (code name L‑AmB).

The purpose is to determine whether this combination improves the overall response to treatment after four weeks. After enrollment, participants start the medication regimen and attend several clinic visits over the next weeks, during which blood tests and imaging are performed. A CT scan may be used to view the infection’s size, and a laboratory test called qPCR will detect fungal DNA.

Safety is monitored throughout the study by recording any side effects, and participants are followed for up to six months to assess longer‑term health outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and Baseline Evaluation

    After joining the study, you will provide informed consent and undergo initial assessments that include medical history, physical examination, laboratory tests, and imaging studies to confirm the diagnosis of mucormycosis.

    Baseline samples for qPCR testing and a computed tomography (CT) scan will be collected to document the extent of infection before treatment starts.

  2. Step 2

    Initiation of Combination Therapy

    Treatment begins on Day 1 with two concurrent medications:

    Isavuconazole is administered orally as hard capsules containing a total dose of 200 mg per day.

    A second formulation of isavuconazole is given by infusion, providing a dose of 600 mg per infusion.

    In addition, liposomal amphotericin B is infused at a high dose of 10 mg per kilogram of body weight. This infusion is given intermittently according to the study schedule.

  3. Step 3

    Early Monitoring (Days 1–14)

    During the first two weeks, you will have regular visits for safety checks, including assessment of any adverse events and repeat laboratory testing.

    A CT scan is performed on Day 14 to evaluate radiological response.

    qPCR tests are conducted on Day 7 and Day 14 to measure fungal DNA levels and to determine whether the test becomes negative.

  4. Step 4

    Week 4 Assessment

    At the end of week 4, a comprehensive evaluation is performed to determine the global response to treatment. This includes clinical examination, repeat imaging, and laboratory tests.

    The primary goal at this point is a favorable global response, defined as either a complete or partial improvement according to adapted response criteria.

    Blood levels of isavuconazole are measured on Day 7, Day 14, and at week 4 to ensure adequate drug exposure.

  5. Step 5

    Continued Treatment and Follow‑up (Week 6 and Month 3)

    Treatment continues beyond week 4, and you will be seen again at week 6 and at month 3 for further assessment of efficacy and safety.

    Evaluations at these time points include clinical status, imaging studies, and repeat qPCR testing.

    Survival and any new adverse events are recorded throughout this period.

  6. Step 6

    Final Follow‑up (Month 6)

    A final visit occurs at month 6 to document long‑term outcomes, including survival status and any late adverse events.

    All study data are compiled to determine the overall success of the combination therapy in treating mucormycosis.

Who can join the trial?

6 criteria

  • You must be an adult who is at least 18 years old.
  • You must have a probable or proven localized mucormycosis infection, diagnosed using special guidelines called the modified EORTC/MSGERC criteria. This includes having risk factors such as diabetes or a recent injury, and a positive blood test known as serum qPCR.
  • You must join the study no later than five days after starting curative treatment for mucormycosis.
  • If you are a woman who could become pregnant (childbearing potential), you must agree to use a highly effective birth control method for the entire treatment period (4 weeks) and for about 32 days after the last dose of the study medication.
  • You (or a close relative) must sign a written form showing you understand the study, known as informed consent.
  • You must have social security coverage (be enrolled in or eligible for it).

Who cannot join the trial?

13 criteria

  • Having spread (disseminated mucormycosis) infection throughout the body.
  • Taking medicines that strongly affect the CYP3A4 enzyme (such as rifampin, carbamazepine, St. John’s Wort, long‑acting barbiturates, ketoconazole, or high‑dose ritonavir) and cannot stop them before joining the study.
  • Receiving palliative care or being expected to live less than one month (not counting the mucormycosis itself).
  • Testing positive for ßHCG (a pregnancy test), being pregnant, or breastfeeding.
  • Already participating in another clinical trial that uses medicines for humans.
  • Having brain infection (cerebral mucormycosis) shown by a brain scan that looks like the infection.
  • Being in the Intensive Care Unit at the time of enrollment and having an active blood‑cancer (hematological malignancy) or a solid organ transplant (solid organ transplantation).
  • Having received curative doses of L‑AmB or ISZ for more than 5 consecutive days within the 15 days before enrollment.
  • Having a simultaneous infection with cryptococcosis (another type of fungal infection).
  • Having a severe allergy to polyene or azole medicines (two classes of antifungal drugs).
  • Having a known allergy to peanuts or soy.
  • Having severe liver disease classified as Child‑Pugh Class C (the most serious level of liver impairment).
  • Having a known family history of short QT syndrome (a heart rhythm disorder).
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Investigated drugs

  • Isavuconazole

    is an antifungal medicine that can be taken by mouth as a capsule or given through a vein as an infusion. In this study it is used to treat mucormycosis, a serious fungal infection. The drug works by stopping the fungus from making its cell wall, which helps the body’s immune system clear the infection. Patients receive it as part of a combination plan, meaning it is given together with another antifungal to improve the chance of recovery.

  • Liposomal amphotericin B

    is a special form of the antifungal drug amphotericin B that is packaged in tiny fat‑like particles (liposomes). This formulation allows higher doses to be given safely through an IV infusion, but only for short, intermittent periods. It attacks the fungus directly by binding to its cell membrane, causing the fungus to die. In the trial it is combined with isavuconazole to see if the two drugs together work better against mucormycosis.

What is already known about the treatment

  • CRESEMBA 100 mg hard capsules

    This medication is taken by mouth as a hard capsule, delivering the antifungal agent isavuconazonium sulfate. It is an approved drug used to treat serious fungal infections such as invasive aspergillosis and mucormycosis and is well described in medical literature. The drug belongs to the triazole class and works by blocking a key enzyme that fungi need to build their cell membrane, weakening the fungus. It is considered a standard oral option for these infections.

  • CRESEMBA 200 mg powder for concentrate for solution for infusion

    This form is reconstituted into a liquid and given through an IV infusion, providing the same active ingredient, isavuconazonium sulfate. It is also an approved antifungal for invasive aspergillosis and mucormycosis and is widely referenced in clinical studies. Like the capsule, it is a triazole that stops the fungus from making an essential cell‑membrane component, leading to fungal death. It offers a rapid, controlled way to deliver the drug when oral intake is not possible.

  • AMBISOME liposomal 50 mg, poudre pour dispersion pour perfusion

    This product is a sterile powder that is mixed with liquid and administered by IV infusion as a liposomal amphotericin B formulation. It is an established, FDA‑approved treatment for severe fungal infections, including mucormycosis, and is frequently cited in the medical literature. It belongs to the polyene class and works by binding to the fungal cell‑membrane sterol ergosterol, creating holes that cause the cell to leak and die. The liposomal delivery allows higher doses to be given safely on an intermittent schedule.

Investigated diseases

Mucormycosis - Mucormycosis is a fungal infection caused by molds of the order Mucorales. It commonly starts in the sinuses, lungs, or skin after the fungi enter the body through inhalation or a wound. The infection can grow rapidly and spread into surrounding tissues. It often invades blood vessels, leading to reduced blood flow and tissue damage. If untreated, the disease may move from a localized area to involve multiple organs. The condition is more frequent in adults with weakened immune systems.
Trial detailsLast updated 12 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521505-40-00Protocol codeAPHP240922Estimated enrolment52 patientsSponsorAssistance Publique Hopitaux De Paris

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