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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized open label interventional phase 2 pilot study to evaluate safety and efficacy of recombinant Interferon-Gamma 1b in patients with candidemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Horizon 2020 - European Commission
• Treatments: Interferon-gamma; Interferons

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 96 hours prior to study entry.

• Subjects who have clinical evidence of infection sometime within 96 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 vasopressive 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.

Exclusion Criteria:

• Subjects with a history of allergy or intolerance to rIFN-γ.

• 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).

• 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 72 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry.