Safety and Efficacy of Immunotherapy in Patients With Candidemia
- Conditions
- CandidemiaTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2020-003204-13-NL
- Lead Sponsor
- Radboudumc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
•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 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.
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
•Subjects with a history of allergy or intolerance to rIFN-?.
•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).
•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 72 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): Time to first negative blood culture;Timepoint(s) of evaluation of this end point: Daily during therapy;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.<br><br>;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>
- Secondary Outcome Measures
Name Time Method