Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia

Study Overview
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Brief Summary
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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

Official Title
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A Multicentre, Prospective, Randomized Open-label Pilot Study to Assess the Feasibility and Preliminary Efficacy of Interferon-gamma in Combination With Anidulafungin for the Treatment of Candidemia

Conditions
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Candidemia

Intervention / Treatment
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* Drug: Interferon-gamma, Recombinant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interferon-gamma<br> | Drug: Interferon-gamma, Recombinant<br>* Interferon 50 mcg/m2 to be administered three times per week during two weeks<br>|
| No Intervention: No intervention<br>No adjunctive treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | until 8 weeks after end of treatment | 
| time to death |  | Until 8 weeks after end of treatment | 
| outcome of fungal infection | resolution at week 2 and 8 after end of treatment, patient status at end of therapy, microbiological parameters | Until 8 weeks after end of treatment | 
| duration of antifungal therapy |  | Until end of treatment | 
| duration of hospitalization |  | Until end of hospitilization | 
| immunological parameters |  | Until 8 weeks after end of treatment | 
| tolerability and safety |  | until 8 weeks after end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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candidemia, candida sepsis, invasive fungal disease