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Immune booster shows promise in fighting dangerous fungal infection
NCT ID NCT04979052
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tested whether adding interferon-gamma to standard antifungal treatment helps clear Candida from the blood faster. 65 adults with candidemia received the drug or standard care alone. The study is completed, and results will show if this combination is safe and speeds up recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Interferon gamma-1b (Immukin)
- What this could lead to
- If it works, this could offer a way to help the immune system fight Candida bloodstream infections more quickly, reducing hospital stays.
- What could go wrong
- This is an early Phase 2 trial with only 65 participants, so results may not apply to everyone. Adding an immune booster may also cause side effects like fever or inflammation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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65 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Mar 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males or non-pregnant females (who must agree to use barrier methods of contraception during the study therapy period, women of childbearing age must have a negative urine pregnancy or serum test at baseline). * Subjects who are 18 years of age or older. * Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 120 hours prior to study entry. * Subjects who have clinical evidence of infection sometime within 120 hours prior to enrolment, including at least one of the following: * Temperature \>37.8 ˚C on two occasions at least four hours apart or one measurement \> 38.2 ˚C * Systolic blood pressure \<90 or a \>30 mmHg decrease in systolic blood pressure from the subject's normal baseline or the need for vassopressive therapy. * Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (e.g. joint, skin, eye, bone, oesophagus). * Radiologic findings of invasive candidiasis. * Subject or their legal representative must sign a written informed consent form. * In case a patient eligible to participate in this study is incapacitated and as such unable to personally provide informed consent, a written consent form must be signed by their legal representative. * Only incapacitated patients that can be expected to regain the capability to consent will be included in this study. In this case, informed consent will be discussed personally with the study participant after recovery. * The inclusion of incapacitated subjects will only be performed under the above conditions in a country in which such an approach is legal and deemed ethically acceptable. Exclusion Criteria: * 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. * Subjects with a history of documented epileptic seizures. * Subjects with severe liver failure ((\>5x upper limit AST or ALT or impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time). * Treatment with heterologous serum proteins, or immunological preparations such as vaccines, toxins, serums and allergens within three days before trial enrolment. * Women who are pregnant or lactating. * Subjects who are unlikely to survive more than 24 hours. * Subjects who have failed previous systemic antifungal therapy for the Candida spp. infection which is being studied. * Subjects who have received more than 120 hours of systemic antifungal therapy for the current episode, within 120 hours prior to study entry. * With respect to incapacitated subjects: * Any patient that is deemed incapable of personally providing informed consent due to a neurodegenerative disease, genetic syndrome, and/or perinatal asphyxia, will not be eligible for inclusion in this trial. * Any incapacitated subject that is not expected to recover to a point where they will personally be able to provide informed consent will not be eligible for inclusion in this trial. Patients with renal failure or dialysis do not have a contraindication for treatment with rIFN-y and can be included in this study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Centre Hospitalier Universitaire Vaudois
Lausanne, 1005, Switzerland
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Duke University
Durham, North Carolina, 27708, United States
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Hellenic Institute for the Study of Sepsis (HISS)
Athens, 11528, Greece
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Klinikum Der Johann Wolfgang Von Goethe Universitaet
Frankfurt am Main, 60590, Germany
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Radboudumc
Nijmegen, Gelderland, 6525 GA, Netherlands
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Universitatea de Medicina si Farmacie luliu Hatieganu
Cluj-Napoca, 400348, Romania
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New drug could shield transplant patients from deadly fungal infections
- Blood test may speed up deadly fungal infection diagnosis