← Back to Search

Cytokine

Interferon Gamma-1B for Candida Blood Infection

Phase 2
Recruiting
Led By Frank vd Veerdonk, Dr.
Research Sponsored by Radboud University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with clinical evidence of infection within 120 hours prior to enrollment, 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 vasopressor therapy, Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (e.g. joint, skin, eye, bone, esophagus), Radiologic findings of invasive candidiasis, Subject or their legal representative must sign a written informed consent form
Subjects who are 18 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
Awards & highlights

Study Summary

This trial is testing if a drug called rIFN-y is safe and effective in treating patients with candidemia, which is a blood infection.

Who is the study for?
Adults with a recent Candida blood infection confirmed by a positive culture, showing signs of infection like fever or low blood pressure, and not severely ill to survive less than 24 hours. They must consent to the study (or have a legal representative do so) and agree to use contraception if applicable. Excluded are those with severe liver failure, history of seizures, recent immunological treatments, pregnant or lactating women, failed prior antifungal therapy for this infection.Check my eligibility
What is being tested?
The trial is testing Interferon Gamma-1B's safety and effectiveness in treating patients with candidemia. It's an open-label phase 2 study where all participants know they're receiving the treatment as researchers observe outcomes.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Interferon Gamma-1B or its ingredients, possible irritation at injection sites, flu-like symptoms such as fever and chills, fatigue or changes in blood cell counts leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to first negative blood culture
Secondary outcome measures
Adverse events
BMI
Body weight
+9 more

Trial Design

2Treatment groups
Active Control
Group I: Interferon-GammaActive Control1 Intervention
Recombinant Interferon-Gamma 1b combined with standard therapy
Group II: Standard of careActive Control1 Intervention
Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines.

Find a Location

Who is running the clinical trial?

Radboud UniversityLead Sponsor
728 Previous Clinical Trials
298,502 Total Patients Enrolled
Radboud University Medical CenterLead Sponsor
1,150 Previous Clinical Trials
1,007,805 Total Patients Enrolled
Horizon 2020 - European CommissionOTHER
31 Previous Clinical Trials
13,676 Total Patients Enrolled

Media Library

Interferon Gamma-1B (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04979052 — Phase 2
Candida Blood Infection Clinical Trial 2023: Interferon Gamma-1B Highlights & Side Effects. Trial Name: NCT04979052 — Phase 2
Interferon Gamma-1B (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04979052 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are investigators actively looking for participants for this experiment?

"Yes, an examination of the clinicaltrials.gov website indicates that this study is actively recruiting patients. According to the information available, the trial was first posted on March 15th, 2022 and was last updated on March 14th, 2022. The research team is looking for 200 individuals to take part in the study at a single site."

Answered by AI

To the best of your knowledge, does anything like this exist?

"At the moment, there are 9 ongoing studies on Interferon-Gamma being conducted in 13 cities and 8 countries. The first study was completed way back in 2011 by BioMérieux. That particular trial only involved 20 patients, but it did manage to reach Phase 3 approval. In total, 25 studies have been done since then."

Answered by AI

How many participants are involved in this research project?

"Yes, this research study is looking for volunteers at the moment. The listing was put up on March 15th, 2022 and updated March 14th, 2022. They are trying to find 200 individuals total from one location."

Answered by AI

Are there any risks that come with treatment by Interferon-Gamma?

"Interferon-Gamma was given a safety score of 2. This is because, although there is data supporting its safety, there is none yet backing up claims of efficacy in Phase 2 trials."

Answered by AI

Could you give some more examples of where Interferon-Gamma has been used in other medical research?

"Currently, there are 9 different Interferon-Gamma trials underway. 1 of these is in Phase 3. Most of the testing for this treatment is happening in Madison, Wisconsin; however, clinical research regarding Interferon-Gamma is being conducted at 39 different locations."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia
2022. "Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04979052.
~48 spots leftby Jan 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top