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Study of Recombinant Interferon-Gamma 1b Combined with Standard Treatment for Patients with Candidemia: Safety and Effectiveness Evaluation

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What is this trial about?

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

This study focuses on patients with candidemia, which is a serious blood infection caused by Candida yeast. The research evaluates a treatment that combines standard therapy with a medication called recombinant interferon gamma-1b (rIFN-gamma 1b). This medication is given as a subcutaneous injection, which means it is injected under the skin.

The purpose of this research is to determine if adding rIFN-gamma 1b to the standard treatment helps clear the Candida infection from the blood more effectively. During the study, participants receive either the study medication along with standard therapy or standard therapy alone. The treatment period lasts up to 2 months, with the medication being administered under the skin at a dose of up to 50 micrograms per square meter of body surface.

Throughout the study, doctors monitor how quickly the infection clears from the blood and track the overall health status of participants. They also observe how well patients tolerate the treatment and any changes in their condition. Blood samples are collected to measure various health indicators and to study how the treatment affects the body's immune response to the infection.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial blood culture confirmation

    Your participation begins after a positive blood test confirms the presence of Candida (a type of fungal infection in the blood).

    This blood test must have been performed within the last 120 hours (5 days).

    You must also show signs of infection such as: fever above 37.8°C, low blood pressure, or visible signs of inflammation.

  2. Step 2

    Treatment initiation

    You will receive two types of treatment:

    Standard therapy for fungal blood infection

    Recombinant interferon gamma 1b (study medication) through subcutaneous injection (under the skin)

  3. Step 3

    Blood culture monitoring

    Regular blood samples will be taken to check if the fungal infection is clearing from your blood

    The main goal is to achieve a negative blood culture within the first 7 days of treatment

  4. Step 4

    Health monitoring during treatment

    Your overall health status will be monitored, including:

    Body weight and nutrition measurements

    Blood tests for various health markers

    Monitoring of organ function

    Recording of any side effects that may occur

  5. Step 5

    Follow-up evaluations

    Your condition will be evaluated at several points:

    At the end of study treatment

    14 days after treatment ends

    28 days after treatment ends

    These evaluations will check your recovery progress and overall health status

Who can join the trial?

9 criteria

  • Must be at least 18 years old
  • Can be male or female, but females must not be pregnant and must:
    • Use barrier methods of contraception during the study
    • Take a pregnancy test before starting the study if of childbearing age
    • Must have at least one positive blood test for Candida (a type of fungal infection) within the last 120 hours before joining the study
    • Must show signs of infection within the last 120 hours before joining, including at least one of these:
      • Fever (temperature above 37.8°C twice with 4 hours apart, or one reading above 38.2°C)
      • Low blood pressure (below 90) or a significant drop in blood pressure, or requiring medication to maintain blood pressure
      • Signs of inflammation like swelling, warmth, redness, or drainage from infected areas
      • X-ray or scan evidence showing fungal infection
      • Must sign an informed consent form (or have a legal representative sign it)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Pregnant or breastfeeding women
  • Known allergy or hypersensitivity to interferon gamma (the study medication) or any of its components
  • Active or chronic autoimmune disease (conditions where the immune system attacks healthy cells)
  • Severe liver dysfunction or failure
  • Severe kidney dysfunction or failure (requiring dialysis)
  • Current participation in other clinical trials
  • Life-threatening conditions requiring intensive care
  • Neutropenia (very low white blood cell count) with counts below 500 cells/μL
  • Active cancer undergoing chemotherapy
  • History of organ transplantation
  • Severe heart conditions or unstable cardiovascular disease
  • Known HIV infection or other severe immunodeficiency conditions
  • Unable to provide informed consent
  • History of seizures or severe neurological disorders
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Investigated drugs

Recombinant Interferon-Gamma 1b is a laboratory-made version of a natural protein that helps boost the immune system's ability to fight infections. In this trial, it is being tested as an additional treatment alongside standard antifungal therapy to help fight bloodstream infections caused by Candida (a type of yeast). This medication aims to enhance the body's natural defense mechanisms against fungal infections. Standard antifungal therapy (which typically includes medications like fluconazole, echinocandins, or amphotericin B) is used to directly fight the Candida infection in the bloodstream. These medications work by either killing the fungal cells or preventing them from growing and spreading further in the body.

What is already known about the treatment

Recombinant Interferon-Gamma 1b – A therapeutic protein administered through injection that belongs to the class of immunomodulatory agents. This medication is designed to enhance the body's immune response against fungal infections, particularly in cases of candidemia (bloodstream Candida infection). It works by stimulating specific immune cells and promoting the production of proteins that help fight infections, acting as a supplement to standard antifungal treatments. The medication represents an innovative approach in treating severe fungal infections by combining the body's natural defense mechanisms with conventional therapeutic strategies.

Investigated diseases

Candidemia - A blood infection caused by Candida fungi, which normally live on the skin and inside the body. The condition occurs when Candida enters the bloodstream and spreads through blood vessels to various parts of the body. Candidemia typically develops in people whose immune systems are weakened or who have undergone medical procedures. The infection can affect multiple organs as the fungi travel through the bloodstream. This condition usually starts gradually and can progress over time if not addressed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510816-55-00Protocol code109864Estimated enrolment200 patientsSponsorStichting Radboud universitair medisch centrum

sourced from the EU Clinical Trials Register and site verification

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Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).