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 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.