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

Launched by RADBOUD UNIVERSITY MEDICAL CENTER · Jul 16, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of a treatment called Interferon-Gamma 1b (rIFN-γ) for patients with candidemia, which is a serious infection caused by a type of yeast called Candida. The study is currently looking for participants who are at least 18 years old and have a confirmed Candida infection from a blood test taken within the last five days. Eligible participants include both men and women, although women of childbearing age must agree to use birth control during the study and have a negative pregnancy test before starting.

If someone joins the study, they will receive rIFN-γ and be monitored closely by healthcare professionals to ensure their safety and track how well the treatment is working. Participants will need to provide informed consent, meaning they agree to take part in the study after being fully informed about what it involves. It's important to note that certain individuals, such as those with specific allergies, severe health conditions, or those who are pregnant or breastfeeding, cannot participate in this trial. This study aims to find better treatment options for patients experiencing candidemia, which can be life-threatening if not treated effectively.

Gender

ALL

Eligibility criteria

• Inclusion 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.
• • 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.
• Exclusion Criteria:
• • 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:
• • 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