A multi-center open label adaptive randomized interventional phase 2 study to evaluate safety and efficacy of rIFN-y treatment in patiens with candidemia.
A multi-center open label adaptive randomized interventional phase 2 study to evaluate safety and efficacy of rIFN-y treatment in patiens with candidemia. Patients will be randomized 1:1 between intervention (rIFN-y immunotherapy, subcutaneous dose of 100miicrogram thrice weekly for two weeks or until hospital discharge) in addition to standard of care versus controls (standard of care). Standard of care antifungal therapy is according to ESCMID/EFISG (Europe) or IDSA (US) guidelines. We will assess the effect on clinical outcome and investigate relevant biomarkers that can guide this immunotherapeutic approach.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
100 microgram per day, three times a week, subcutaneous. The duration of the treatment is twelve days or until hospital discharge.
Duke University
Durham, North Carolina, United States
RECRUITINGKlinikum Der Johann Wolfgang Von Goethe Universitaet
Frankfurt am Main, Germany
RECRUITINGHellenic Institute for the Study of Sepsis (HISS)
Athens, Greece
Time to first negative blood culture
Time frame: Day 14
Time to treatment success
microbiological eradication of Candida from the blood and any other site of infection; resolution of fever; resolution of other diagnostic variables, such as imaging results, where applicable; and no new signs of infection. The time at which all the variables are met is defined as the date of resolution of infection.
Time frame: Day 14
Percentage of patients with mycological outcomes
Time frame: through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
Percentage of patients with treatment success
Time frame: through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
Overall survival
Time frame: Study day 28
Number of patients with Treatment Emergent Adverse Events (TEAEs).
Time frame: Study day 49
Sequential Organ Failure Assessment (SOFA) score
Time frame: Study day 14
Adverse events
Time frame: Study day 14
Body weight
kg
Time frame: Study day 49
BMI
kg/m\^2
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Radboudumc
Nijmegen, Gelderland, Netherlands
RECRUITINGUniversitatea de Medicina si Farmacie luliu Hatieganu
Cluj-Napoca, Romania
RECRUITINGCentre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
RECRUITINGTime frame: Study day 49
Prealbumin
mg/dl
Time frame: Study day 49
Total lymphocytes
10\^9/L
Time frame: Study day 49
Cholesterol
mmol/L
Time frame: Study day 49