Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia

Conditions

Candidemia

Brief summary

Time to first negative blood culture.

Detailed description

Time of resolution to infection (composite endpoint)., Percentage of patients with mycological outcomes at EOST, EOT, and day 14 and day 28 after EOT., Percentage of patients with treatment success at EOST, EOT, and day 14 and day 28 after EOT., Overall survival at Study Day 28., Number of patients with Treatment Emergent Adverse Events (TEAEs)., Evaluation of patient status at end of rIFN-γ treatment including organ (dys)function (Sequential Organ Failure Assessment [SOFA] score), and adverse events, Nutritional status (body weight, BMI), nutritional blood parameters (prealbumin, total lymphocytes, cholesterol)., Genetics and transcriptomics., Gut microbiota composition and Candida genomics and metabolomics, Changes in circulating cytokines, biomarkers, LAP activation, inflammasome, and immunoprofiling.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGIMMUKINE

DRUGoplossing voor injectie 2 x 10^6 IE (0

DRUG1 mg)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time to first negative blood culture.	—

Secondary

Measure	Time frame
Time of resolution to infection (composite endpoint)., Percentage of patients with mycological outcomes at EOST, EOT, and day 14 and day 28 after EOT., Percentage of patients with treatment success at EOST, EOT, and day 14 and day 28 after EOT., Overall survival at Study Day 28., Number of patients with Treatment Emergent Adverse Events (TEAEs)., Evaluation of patient status at end of rIFN-γ treatment including organ (dys)function (Sequential Organ Failure Assessment [SOFA] score), and adverse events, Nutritional status (body weight, BMI), nutritional blood parameters (prealbumin, total lymphocytes, cholesterol)., Genetics and transcriptomics., Gut microbiota composition and Candida genomics and metabolomics, Changes in circulating cytokines, biomarkers, LAP activation, inflammasome, and immunoprofiling.	—

Measure

Time frame

Time of resolution to infection (composite endpoint)., Percentage of patients with mycological outcomes at EOST, EOT, and day 14 and day 28 after EOT., Percentage of patients with treatment success at EOST, EOT, and day 14 and day 28 after EOT., Overall survival at Study Day 28., Number of patients with Treatment Emergent Adverse Events (TEAEs)., Evaluation of patient status at end of rIFN-γ treatment including organ (dys)function (Sequential Organ Failure Assessment [SOFA] score), and adverse events, Nutritional status (body weight, BMI), nutritional blood parameters (prealbumin, total lymphocytes, cholesterol)., Genetics and transcriptomics., Gut microbiota composition and Candida genomics and metabolomics, Changes in circulating cytokines, biomarkers, LAP activation, inflammasome, and immunoprofiling.

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Countries

Germany, Greece, Netherlands, Romania

Outcome results

None listed