Candida bloodstream infections/ candidemia MedDRA version: 12.1 Level: LLT Classification code 10042938 Term: Systemic candida MedDRA version: 12.1 Level: LLT Classification code 10042939 Term: Systemic candidiasis MedDRA version: 12.1 Level: LLT Classification code 10049160 Term: Candidaemia MedDRA version: 12.1 Level: PT Classification code 10053166 Term: Candida sepsis MedDRA version: 12.1 Level: LLT Classification code 10060573 Term: Candidemia MedDRA version: 12.1 Level: LLT Classific
Conditions
Interventions
Trade Name: Immukine
Product Name: Interferon gamma
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INTERFERON GAMMA
CAS Number: 82115-62-6
Concentration unit: µg microgram(s)
Concent
Sponsors
University Medical Center Nijmegen
Eligibility
Sex/Gender
All
Inclusion criteria
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 old 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 ENROLLMENT, including AT LEAST ONE of the following: -Temperature >37.8 °C on 2 occasions at least 4 hours apart or one determination measurement > 38.2 °C -Systolic blood pressure 30 mmHg decrease in systolic BP from the subject’s normal baseline. -Signs of inflammation (swelling, heat, erythema, purulent drainage) from a site infected with Candida (eg, joint, skin, eye, bone, esophagus) -Radiologic findings of invasive canidiasis •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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Subjects with a history of allergy or intolerance to echinocandines or IFNgamma •Subjects with an absolute neutrophil count of less than 500/mm3 at study entry •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 48 hours of systemic antifungal therapy for the current episode, within 96 hours prior to study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the (preliminary) efficacy of interferon gamma as adjunctive treatment in combination with standard therapy for the treatment of patients with candidemia by assessment of a series of exploratory parameters. The primary endpoint is to compare the time to negative blood cultures.;Secondary Objective: Secondary endpoints are the overall survival, time to death, outcome of fungal infection (resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters) duration of antifungal therapy, duration of hospitalization and immunological parameters. A secondary aim will be to evaluate host response markers that could be used to identify patients with immunoparalysis who will benefit from immunotherapy, and to monitor the patient’s immunological response to IFN-gamma. ;Primary end point(s): The primary endpoint is the time to negative blood cultures. | — |
Countries
Netherlands
Outcome results
None listed