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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
General Hospital Of Chania Agios Georgios Chania Greece

Other Sites

Site Name City Country Status
University General Hospital Of Heraklion Heraklion Greece
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
424 Military General Training Hospital Thessaloniki Greece
Asklepieion Voulas General Hospital Voula Greece
General Hospital Of Thessloniki G Gennimatas Thessaloniki Greece
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Ioannina Ioannina Greece
Stichting Radboud University Medical Center Nijmegen The Netherlands
General University Hospital Of Patras Patras Greece
General Hospital Of Athens Korgialenio Benakio H.R.C. Athens Greece
General Oncological Hospital Of Kifissia Agioi Anargyroi Kifissia Greece
Skjmiudt Cganwp Da Bvwu Isyljpgwiwt Cpopkgvkfom Cluj Napoca Romania
Txknwviwzx Chmtje Hknhyyve Thessaloniki Greece
Lrwpv Gdqocrx Hubazwes Od Aszklv Athens Greece
Adoaliwbu Uka Amsterdam The Netherlands
Gnvpme Ufzroyrrbn Fhjzftkoi Frankfurt Germany
Ulmjvvqqof Gdnaejv Hydtdypr Akwndfa Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.01.2022
Greece Greece
Not recruiting
01.01.2022
Romania Romania
Not recruiting
01.01.2022
The Netherlands The Netherlands
Not recruiting
01.01.2022

Trial locations

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.

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 ID:
2024-510816-55-00
Protocol code:
109864
NCT ID:
NCT04979052
Trial Phase:
Therapeutic exploratory (Phase II)

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