rIFN-Gamma 1b in Candidemia
- Conditions
- Candidemia
- Registration Number
- 2024-510816-55-00
- Lead Sponsor
- Stichting Radboud University Medical Center
- Brief Summary
The primary objective of the study is to evaluate the efficacy and safety of rIFN-γ as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia. Efficacy is defined as clearance of candidemia within the first 7 days of treatment, taking into account mortality.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruitment pending
- Sex
- Not specified
- Target Recruitment
- 125
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
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.
Patients with renal failure or dialysis do not have a contraindication for treatment with rIFNy and can be included in this study.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first negative blood culture. Time to first negative blood culture.
- Secondary Outcome Measures
Name Time Method Time of resolution to infection (composite endpoint). 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 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. Percentage of patients with treatment success at EOST, EOT, and day 14 and day 28 after EOT.
Overall survival at Study Day 28. Overall survival at Study Day 28.
Number of patients with Treatment Emergent Adverse Events (TEAEs). 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 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). Nutritional status (body weight, BMI), nutritional blood parameters (prealbumin, total lymphocytes, cholesterol).
Genetics and transcriptomics. Genetics and transcriptomics.
Gut microbiota composition and Candida genomics and metabolomics Gut microbiota composition and Candida genomics and metabolomics
Changes in circulating cytokines, biomarkers, LAP activation, inflammasome, and immunoprofiling. Changes in circulating cytokines, biomarkers, LAP activation, inflammasome, and immunoprofiling.
Trial Locations
- Locations (18)
Goethe University Frankfurt
🇩🇪Frankfurt Am Main, Germany
Ippokratio General Hospital Of Thessaloniki
🇬🇷Thessaloniki, Greece
424 Military General Training Hospital
🇬🇷Thessaloniki, Greece
General Oncological Hospital Of Kifissia Agioi Anargyroi
🇬🇷Kifissia, Greece
Asklepieion Voulas General Hospital
🇬🇷Voula, Greece
Theageneio Cancer Hospital
🇬🇷Thessaloniki, Greece
Thoracic General Hospital Of Athens I Sotiria
🇬🇷Athens, Greece
General Hospital Of Chania Agios Georgios
🇬🇷Chania, Greece
University General Hospital Attikon
🇬🇷Athens, Greece
University General Hospital Of Heraklion
🇬🇷Heraklion, Greece
Scroll for more (8 remaining)Goethe University Frankfurt🇩🇪Frankfurt Am Main, GermanyMaria VehreschildSite contact0049696301660vehreschild@med.uni-frankfurt.de