Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia
NCT ID: NCT04979052
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2022-03-31
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interferon-Gamma
Recombinant Interferon-Gamma 1b combined with standard therapy
Interferon Gamma-1B
100 microgram per day, three times a week, subcutaneous. The duration of the treatment is twelve days or until hospital discharge.
Standard of care
Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines.
No interventions assigned to this group
Interventions
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Interferon Gamma-1B
100 microgram per day, three times a week, subcutaneous. The duration of the treatment is twelve days or until hospital discharge.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Horizon 2020 - European Commission
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Frank vd Veerdonk, Dr.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Duke University
Durham, North Carolina, United States
Klinikum Der Johann Wolfgang Von Goethe Universitaet
Frankfurt am Main, , Germany
Hellenic Institute for the Study of Sepsis (HISS)
Athens, , Greece
Radboudumc
Nijmegen, Gelderland, Netherlands
Universitatea de Medicina si Farmacie luliu Hatieganu
Cluj-Napoca, , Romania
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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John R. Perfect, Dr.
Role: primary
Maria Vehreschild, Prof. Dr.
Role: primary
Evangelos Giamarellos-Bourboulis, Prof. Dr.
Role: primary
Frank vd Veerdonk, Prof. Dr.
Role: primary
Mihaela Sorina Lupse, Dr.
Role: primary
Thierry Calandra, Prof. Dr.
Role: primary
Other Identifiers
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HDM-FUN-Candidemia
Identifier Type: -
Identifier Source: org_study_id