NCT04979052

Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Candidemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-31
• Primary completion: 2026-04-23
• Completion: 2026-04-23
• First posted: 2021-07-27
• Last updated: 2026-04-01

Locations

6 sites across 6 countries: United States, Germany, Greece, Netherlands, Romania, Switzerland

Regulatory

• FDA-regulated drug study