Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia
Study Details
Study Description
Brief Summary
A multi-center open label adaptive randomized interventional phase 2 study to evaluate safety and efficacy of rIFN-y treatment in patiens with candidemia.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Interferon-Gamma Recombinant Interferon-Gamma 1b combined with standard therapy |
Drug: 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 Names:
|
No Intervention: Standard of care Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines. |
Outcome Measures
Primary Outcome Measures
- Time to first negative blood culture [Day 14]
Secondary Outcome Measures
- Time to treatment success [Day 14]
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.
- Percentage of patients with mycological outcomes [through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion]
- Percentage of patients with treatment success [through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion]
- Overall survival [Study day 28]
- Number of patients with Treatment Emergent Adverse Events (TEAEs). [Study day 49]
- Sequential Organ Failure Assessment (SOFA) score [Study day 14]
- Adverse events [Study day 14]
- Body weight [Study day 49]
kg
- BMI [Study day 49]
kg/m^2
- Prealbumin [Study day 49]
mg/dl
- Total lymphocytes [Study day 49]
10^9/L
- Cholesterol [Study day 49]
mmol/L
Eligibility Criteria
Criteria
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).
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Subjects who are 18 years of age or older.
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Subjects with at least one positive blood culture isolation of Candida species from a specimen drawn within 96 hours prior to study entry.
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Subjects who have clinical evidence of infection sometime within 96 hours prior to enrolment, including at least one of the following:
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Temperature >37.8 ˚C on two occasions at least four hours apart or one measurement > 38.2 ˚C
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Systolic blood pressure <90 or a >30 mmHg decrease in systolic blood pressure from the subject's normal baseline or the need for vasopressive therapy.
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Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (e.g. joint, skin, eye, bone, oesophagus).
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Radiologic findings of invasive candidiasis.
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Subject or their legal representative must sign a written informed consent form.
Exclusion Criteria:
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Subjects with a history of allergy or intolerance to rIFN-γ.
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Subjects with a history of documented epileptic seizures.
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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).
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Women who are pregnant or lactating.
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Subjects who are unlikely to survive more than 24 hours.
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Subjects who have failed previous systemic antifungal therapy for the Candida spp. infection which is being studied.
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Subjects who have received more than 72 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Duke University | Durham | North Carolina | United States | 27708 |
2 | Klinikum Der Johann Wolfgang Von Goethe Universitaet | Frankfurt am main | Germany | 60590 | |
3 | Radboudumc | Nijmegen | Gelderland | Netherlands | 6525 GA |
4 | Universitatea de Medicina si Farmacie luliu Hatieganu | Cluj-Napoca | Romania | 400348 | |
5 | Centre Hospitalier Universitaire Vaudois | Lausanne | Switzerland | 1005 |
Sponsors and Collaborators
- Radboud University Medical Center
- Horizon 2020 - European Commission
Investigators
- Principal Investigator: Frank vd Veerdonk, Dr., Radboud University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HDM-FUN-Candidemia