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

Inclusion Criteria:

• Males or non-pregnant females (who must agree to use barrier methods ofcontraception during the study therapy period, women of childbearing age must have anegative 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 froma specimen drawn within 120 hours prior to study entry.

• Subjects who have clinical evidence of infection sometime within 120 hours prior toenrolment, including at least one of the following:

• Temperature >37.8 ˚C on two occasions at least four hours apart or onemeasurement > 38.2 ˚C

• Systolic blood pressure <90 or a >30 mmHg decrease in systolic blood pressurefrom the subject's normal baseline or the need for vassopressive therapy.

• Signs of inflammation (swelling, heat, erythema, purulent drainage) from a siteinfected 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 suchunable to personally provide informed consent, a written consent form must be signedby their legal representative.

• Only incapacitated patients that can be expected to regain the capability toconsent will be included in this study. In this case, informed consent will bediscussed personally with the study participant after recovery.

• The inclusion of incapacitated subjects will only be performed under the aboveconditions in a country in which such an approach is legal and deemed ethicallyacceptable.

Exclusion Criteria:

• Subjects with a history of allergy or intolerance to rIFN-γ,or any other IMPingredient 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 impairedsynthesis of proteins such as coagulation factors manifested by increasedprothrombin time).

• Treatment with heterologous serum proteins, or immunological preparations such asvaccines, 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 forthe 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 toa neurodegenerative disease, genetic syndrome, and/or perinatal asphyxia, will notbe eligible for inclusion in this trial.

• Any incapacitated subject that is not expected to recover to a point where they willpersonally be able to provide informed consent will not be eligible for inclusion inthis trial. Patients with renal failure or dialysis do not have a contraindicationfor treatment with rIFN-y and can be included in this study