Safety and Efficacy of Immunotherapy in Patients With Candidemia

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the efficacy and safety and rIFN-? as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia. Efficacy is defined as clearance of candidemia within the first 7 days of treatment, taking into account mortality.;Secondary Objective: The secondary objectives of this study are:<br>• To evaluate new markers that could be used to identify patients that respond to immunotherapy with rIFN-?.<br>• To identify markers that can monitor the patient’s immunological and clinical response to rIFN-? immunotherapy. <br>• To perform mechanistic studies to further elucidate mechanisms that are important for host defence against candidemia and the effects of rIFN-? on these mechanisms.<br><br>;Primary end point(s): Time to first negative blood culture.;Timepoint(s) of evaluation of this end point: Daily during therapy.

Secondary Outcome Measures

Name	Time	Method

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