Ongoing study
Official Study Title
Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia: The HDM-FUN-Candidemia trial
Brief Description
Invasive fungal infections are an important cause of morbidity and mortality and lead to numerous hospital and ICU admissions. Candidemia is associated with a suppressed immune status and research has provided evidence that patients with candidemia might benefit from recombinant interferon gamma (rIFN-γ) immunotherapy. This study aims to assess the safety and efficacy of adjunctive rIFN-γ treatment to standard antifungal therapy on outcome in patients with candidemia. The secondary objective is to evaluate new markers that can indicate whether a patient will benefit from rIFN-γ immunotherapy.
Details
Status: Recruiting
Study Type: Interventional
Study phase: II
Study sites: 18 sites in Greece, 1 in Switzerland, 1 in Germany, 1 in Romania, 1 in USA, 1 in the Netherlands
Target of enrolment: 200 participants
ClinicalTrials.gov Identifier: NCT04979052
EudraCT number: 2020-003204-13
National Organization for Medicines Approval: IS188-22
National Ethics Committee Approval: 209/22
Study Start: February 2023
Condition/Disease studied: Candidemia
Keywords: invasive candidiasis; candidemia; recombinant interferon gamma 1b