200 Participants Needed

Interferon Gamma-1B for Candida Blood Infection

(HDM-FUN Cand Trial)

Recruiting at 5 trial locations
Fv
Overseen ByFrank vd Veerdonk, Dr.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

A multi-center open label adaptive randomized interventional phase 2 study to evaluate safety and efficacy of rIFN-y treatment in patiens with candidemia.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been treated with certain immune-related therapies or antifungal treatments recently, you may not be eligible to participate.

What evidence supports the effectiveness of the drug Interferon Gamma-1B for treating Candida blood infections?

Research shows that Interferon Gamma-1B can enhance the body's immune response against fungal infections like Candida by activating certain immune cells. In animal studies, it has been effective in fighting Candida infections, although its effectiveness may be limited in cases of severely weakened immune systems.12345

Is Interferon Gamma-1B generally safe for human use?

Interferon Gamma-1B has been studied in humans for conditions like AIDS-related cryptococcal meningitis and was found to be well tolerated, meaning it did not cause significant side effects. This suggests it is generally safe for human use, although specific safety data for Candida blood infections is not available.13456

How does the drug Interferon Gamma-1B work differently for Candida blood infection?

Interferon Gamma-1B is unique because it boosts the body's immune response by activating certain immune cells to better fight off Candida infections. Unlike standard antifungal drugs, it enhances the body's natural defenses, particularly by increasing the activity of cells that kill the fungus.13578

Research Team

Fv

Frank vd Veerdonk, Dr.

Principal Investigator

Radboud University Medical Center

Eligibility Criteria

Adults with a recent Candida blood infection confirmed by a positive culture, showing signs of infection like fever or low blood pressure, and not severely ill to survive less than 24 hours. They must consent to the study (or have a legal representative do so) and agree to use contraception if applicable. Excluded are those with severe liver failure, history of seizures, recent immunological treatments, pregnant or lactating women, failed prior antifungal therapy for this infection.

Inclusion Criteria

Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 120 hours prior to study entry
I agree to use contraception during the study and, if I'm a woman of childbearing age, I have a negative pregnancy test.
I am 18 years old or older.
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Exclusion Criteria

I am currently pregnant or breastfeeding.
Subjects with a history of allergy or intolerance to rIFN-γ, or any other IMP ingredient or with a history of immediate type hypersensitivity to latex/rubber
I have a documented history of epileptic seizures.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive rIFN-y immunotherapy, subcutaneous dose of 100 microgram thrice weekly for two weeks or until hospital discharge, in addition to standard of care

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 weeks

Treatment Details

Interventions

  • Interferon Gamma-1B
Trial OverviewThe trial is testing Interferon Gamma-1B's safety and effectiveness in treating patients with candidemia. It's an open-label phase 2 study where all participants know they're receiving the treatment as researchers observe outcomes.
Participant Groups
2Treatment groups
Active Control
Group I: Interferon-GammaActive Control1 Intervention
Recombinant Interferon-Gamma 1b combined with standard therapy
Group II: Standard of careActive Control1 Intervention
Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines.

Interferon Gamma-1B is already approved in United States for the following indications:

🇺🇸
Approved in United States as Actimmune for:
  • Chronic granulomatous disease
  • Severe, malignant osteopetrosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radboud University

Lead Sponsor

Trials
729
Recruited
298,000+

Radboud University Medical Center

Lead Sponsor

Trials
1,203
Recruited
1,157,000+

Horizon 2020 - European Commission

Collaborator

Trials
35
Recruited
14,200+

Findings from Research

Cytokines, such as Interleukin-1 and interferon-gamma, show promise as adjunctive therapies to enhance host resistance against invasive fungal infections, particularly in immunocompromised patients.
Interferon-gamma has been effective in boosting the immune response against fungal infections like candidiasis in animal models, primarily by activating neutrophils, although its effectiveness is limited in patients with severe granulocytopenia.
Cytokines in the treatment of fungal infections.Kullberg, BJ., van 't Wout, JW.[2019]
In a randomized controlled trial involving patients with HIV-associated cryptococcal meningitis, the addition of interferon-gamma (IFNγ) to standard therapy significantly increased the rate of fungal clearance from the cerebrospinal fluid, indicating enhanced treatment efficacy.
Both two doses and six doses of IFNγ were equally effective in improving clearance rates, and the treatment was well tolerated with no increase in adverse events, suggesting a safe addition to standard therapy.
Adjunctive interferon-γ immunotherapy for the treatment of HIV-associated cryptococcal meningitis: a randomized controlled trial.Jarvis, JN., Meintjes, G., Rebe, K., et al.[2023]
A single injection of a monoclonal antibody targeting gamma interferon, when given with a live Candida albicans vaccine, led to a nonprotective Th2 immune response instead of the desired protective Th1 response.
This treatment also changed the early expression levels of interleukin 4 and gamma interferon mRNA in CD4+ cells, indicating a significant alteration in the immune response mechanism.
Gamma interferon modifies CD4+ subset expression in murine candidiasis.Romani, L., Cenci, E., Mencacci, A., et al.[2021]

References

Cytokines in the treatment of fungal infections. [2019]
Adjunctive interferon-γ immunotherapy for the treatment of HIV-associated cryptococcal meningitis: a randomized controlled trial. [2023]
Gamma interferon modifies CD4+ subset expression in murine candidiasis. [2021]
Recombinant interferon- gamma 1b as adjunctive therapy for AIDS-related acute cryptococcal meningitis. [2022]
Role of IFN-gamma in immune responses to Candida albicans infections. [2022]
Recombinant interferon-gamma enhances resistance to acute disseminated Candida albicans infection in mice. [2021]
IFN-gamma in Candida albicans infections. [2022]
Interferon-gamma activates the oxidative killing of Candida albicans by human granulocytes. [2019]