Candidemia
Conditions
Keywords
candidemia, candida sepsis, invasive fungal disease
Brief summary
The purpose of this study is to assess the feasibility and preliminary efficacy of interferon-gamma in combination with anidulafungin for the treatment of candidemia
Interventions
Interferon 50 mcg/m2 to be administered three times per week during two weeks
Sponsors
BioMérieux
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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 measurement \> 38.2 ˚C * Systolic blood pressure \<90 or a \>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 candidiasis * Subject or their legal representative must sign a written informed consent form.
Exclusion criteria
* Subjects with a history of allergy or intolerance to echinocandins or IFNgamma * Subjects with a history of documented epileptic seizures * Subjects with severe renal impairment (creatinine clearance less than 30/mL/min) * Subjects with severe liver failure (impaired synthesis of proteins such as coagulation factors manifested by increased prothrombin time) * 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 |
|---|---|
| the time to negative blood cultures | at fixed time points during follow up (at least until 8 weeks after end of treatment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| time to death | Until 8 weeks after end of treatment | — |
| outcome of fungal infection | Until 8 weeks after end of treatment | resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters |
| duration of antifungal therapy | Until end of treatment | — |
| overall survival | until 8 weeks after end of treatment | — |
| immunological parameters | Until 8 weeks after end of treatment | — |
| tolerability and safety | until 8 weeks after end of treatment | — |
| duration of hospitalization | Until end of hospitilization | — |
Countries
Netherlands
Contacts
Primary ContactCorine Delsing, MD
Backup ContactMihai Netea, MD. PhD
Outcome results
None listed