Safety and Efficacy of Recombinant Interferon-Gamma 1b (rIFN-Gamma 1b) Given With Standard Therapy in Patients With Candidemia - rIFN-Gamma 1b in Candidemia

Hellenic Institute for the Study of Sepsis0 个研究点目标入组 200 人开始时间: 2022年12月15日最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•Subject or their legal representative must sign a written informed consent form.
•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 at some time 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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•Age under 18 years old
•Denial to sign informed consent form
•Subjects with a history of allergy or intolerance to rIFN-? or to every other ingredient of the investigational product or history of immediate type hypersensitivity to latex
•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 five days prior to study entry.
•Participation to other interventional study.

发起方