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

NCT04979052 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: HDM-FUN-Candidemia
• Study Type: interventional
• Target: 200
• Locations: 6 countries
• Sites: 6

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.

Conditions

Candidemia

Keywords

Interferon Gamma 1b

Outcome Measures

Primary Outcomes (1)

• Time to first negative blood culture

  Day 14

Secondary Outcomes (12)

• Time to treatment success

  Day 14

• 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

Study Arms (2)

Interferon-Gamma

ACTIVE COMPARATOR

Recombinant Interferon-Gamma 1b combined with standard therapy

Drug: Interferon Gamma-1B

Standard of care

NO INTERVENTION

Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines.

Interventions

Interferon Gamma-1B DRUG

100 microgram per day, three times a week, subcutaneous. The duration of the treatment is twelve days or until hospital discharge.

Also known as: Immukin

Interferon-Gamma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• In case a patient eligible to participate in this study is incapacitated and as such unable to personally provide informed consent, a written consent form must be signed by their legal representative.
• Only incapacitated patients that can be expected to regain the capability to consent will be included in this study. In this case, informed consent will be discussed personally with the study participant after recovery.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Horizon 2020 - European Commission: collaborator

Study Sites (6)

Duke University

Durham, North Carolina, 27708, United States

Location

Klinikum Der Johann Wolfgang Von Goethe Universitaet

Frankfurt am Main, 60590, Germany

Location

Hellenic Institute for the Study of Sepsis (HISS)

Athens, 11528, Greece

Location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Universitatea de Medicina si Farmacie luliu Hatieganu

Cluj-Napoca, 400348, Romania

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, 1005, Switzerland

Location

MeSH Terms

Conditions

Candidemia

Interventions

interferon gamma-1b

Condition Hierarchy (Ancestors)

Candidiasis, Invasive; Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frank vd Veerdonk, Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open label adaptive randomized interventional study

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: July 27, 2021
• Study Start: March 31, 2022
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); US (1); CH (1); GR (1); DE (1); NL (1)