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rIFN-Gamma 1b in Candidemia
EU CTIS ID: 2024-510816-55-00
What this study is testing
The primary objective of the study is to evaluate the efficacy and safety of rIFN-γ as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia. Efficacy is defined as clearance of candidemia within the first 7 days of treatment, taking into account mortality.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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
You likely can't join 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.
- Patients with renal failure or dialysis do not have a contraindication for treatment with rIFNy and can be included in this study.
- 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.
See the full eligibility criteria
- 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
- 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.
- Patients with renal failure or dialysis do not have a contraindication for treatment with rIFNy and can be included in this study.
- 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: • 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.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.