Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: BioMérieux
• Treatments: Anidulafungin; 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 AT SOME TIME WITHIN 96 HOURS PRIOR TO ENROLLMENT, including AT LEAST ONE of the following:

• Temperature >37.8 ˚C on 2 occasions at least 4 hours apart or one measurement > 38.2 ˚C

• Systolic blood pressure <90 or a >30 mmHg decrease in systolic BP from the subject's normal baseline.

• Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (eg, joint, skin, eye, bone, esophagus)

• 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 echinocandins or IFNgamma

• Subjects with a history of documented epileptic seizures

• Subjects with severe renal impairment (creatinine clearance less than 30/mL/min)

• Subjects with severe liver failure (impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time)

• Subjects with an absolute neutrophil count of less than 500/mm3 at study entry

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