CandidemiaPhase 2HDM-FUN CandNCT04979052
Safety and Efficacy of Interferon-Gamma 1b in Patients With Candidemia
A Phase 2 study testing Interferon Gamma-1B in people with Candidemia, run by Radboud University Medical Center at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia
- What is being tested?
- Interferon Gamma-1B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 31 Mar 2022to 30 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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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).
- 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.
- The inclusion of incapacitated subjects will only be performed under the above conditions in a country in which such an approach is legal and deemed ethically acceptable.
Who cannot join
- 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.
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- 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:
- Any patient that is deemed incapable of personally providing informed consent due to a neurodegenerative disease, genetic syndrome, and/or perinatal asphyxia, will not be eligible for inclusion in this trial.
- Any incapacitated subject that is not expected to recover to a point where they will personally be able to provide informed consent will not be eligible for inclusion in this trial. Patients with renal failure or dialysis do not have a contraindication for treatment with rIFN-y and can be included in this study
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Germany1 site
Klinikum Der Johann Wolfgang Von Goethe Universitaet
Frankfurt am Main, 60590
Romania1 site
Universitatea de Medicina si Farmacie luliu Hatieganu
Cluj-Napoca, 400348
About this study
Official title: Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia
A multi-center open label adaptive randomized interventional phase 2 study to evaluate safety and efficacy of rIFN-y treatment in patiens with candidemia.
Read the 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
- Being tested
- Interferon Gamma-1B
- Keywords
- Interferon Gamma 1b
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon Gamma-1BDrug
Also called Immukin
100 microgram per day, three times a week, subcutaneous. The duration of the treatment is twelve days or until hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Interferon-Gamma | Active comparator | Recombinant Interferon-Gamma 1b combined with standard therapy Receives: Drug: Interferon Gamma-1B |
| Standard of care | No intervention | Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first negative blood culture
Measured: Day 14
Secondary outcomes (12)
Time to treatment success
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.
Measured: Day 14
Percentage of patients with mycological outcomes
Measured: through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
Percentage of patients with treatment success
Measured: through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
Overall survival
Measured: Study day 28
Number of patients with Treatment Emergent Adverse Events (TEAEs).
Measured: Study day 49
Sequential Organ Failure Assessment (SOFA) score
Measured: Study day 14
Adverse events
Measured: Study day 14
Body weight
kg
Measured: Study day 49
BMI
kg/m^2
Measured: Study day 49
Prealbumin
mg/dl
Measured: Study day 49
Total lymphocytes
10^9/L
Measured: Study day 49
Cholesterol
mmol/L
Measured: Study day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start31 Mar 2022
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label adaptive randomized interventional study
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Responsible party
- Sponsor
- Investigators
- Frank vd Veerdonk, Dr., Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979052
- Sponsor's protocol ID
- HDM-FUN-Candidemia
- Acronym
- HDM-FUN Cand
- Status last verified
- Apr 2026
- First submitted
- 9 Nov 2020
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia
- ClinicalTrials.gov ID
- NCT04979052
- Acronym / sponsor ID
- HDM-FUN Cand / HDM-FUN-Candidemia
- Conditions
- Candidemia
- Keywords
- Interferon Gamma 1b
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Horizon 2020 - European Commission
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label adaptive randomized interventional study
| Arm | Type | Receives |
|---|---|---|
| Interferon-Gamma | Active comparator | Drug: Interferon Gamma-1BRecombinant Interferon-Gamma 1b combined with standard therapy |
| Standard of care | No intervention | –Standard of care antifungal therapy according tot ESCMID/EFISG (Europe) or ISDA (US) guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Subject or their legal representative must sign a written informed consent form.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon Gamma-1BAlso: Immukin100 microgram per day, three times a week, subcutaneous. The duration of the treatment is twelve days or until hospital discharge. | Drug | Interferon-Gamma |
Primary outcome
Time to first negative blood culture
Time frame: Day 14
12 secondary outcomes
Time to treatment success
Time frame: Day 14
Percentage of patients with mycological outcomes
Time frame: through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
Percentage of patients with treatment success
Time frame: through intervention completion, an average at day 11 and 2 and 4 weeks after intervention completion
Overall survival
Time frame: Study day 28
Number of patients with Treatment Emergent Adverse Events (TEAEs).
Time frame: Study day 49
Sequential Organ Failure Assessment (SOFA) score
Time frame: Study day 14
Adverse events
Time frame: Study day 14
Body weight
Time frame: Study day 49
BMI
Time frame: Study day 49
Prealbumin
Time frame: Study day 49
Total lymphocytes
Time frame: Study day 49
Cholesterol
Time frame: Study day 49
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Candidemia
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Invasive Candidiasis
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
Not yet recruitingPhase 4
Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
Candidemia, Invasive Candidiasis
Not yet recruitingObservational study
A Study Comparing Short-course Antifungal Therapy (SCAT) 7 Day vs Standard 14 Day Antifungal Therapy for Uncomplicated Candidemia
Candidemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank vd Veerdonk, Dr. principal investigator
Radboud University Medical Center
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interferon Gamma-1B in people with Candidemia, run by Radboud University Medical Center at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Germany, Greece, Netherlands, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first negative blood culture (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.