Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.

Official Title
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Open-Label, Non-Comparative, Study Of Intravenous Anidulafungin, Followed Optionally By Oral Voriconazole Or Fluconazole Therapy, For Treatment Of Documented Candidemia/Invasive Candidiasis In Intensive Care Unit Patient Populations

Conditions
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Invasive Candidiasis

Intervention / Treatment
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* Drug: Anidulafungin
* Drug: Fluconazole
* Drug: Voriconazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations: Post-abdominal surgery. Elderly > 65 years old. Renal insufficiency / failure / hemodialysis. Solid tumor. Solid-organ (liver, kidney, lung, heart) transplant recipients. Hepatic insufficiency. Neutropenic including hematology oncology patients. Exclusion Criteria: Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Option to treat with oral azole therapy following treatment with anidulafungin | Drug: Anidulafungin<br>* Anidulafungin Intravenous Administration<br>Drug: Fluconazole<br>* Oral Administration of Fluconazole<br>Drug: Voriconazole<br>* Oral Administration of Voriconazole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Global Treatment Response Success at End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | End of Treatment (Day 14 to Day 56) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | EOIVT (Day 10 up to Day 42) | 
| Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | 2 weeks after End of Treatment (Day 14 + 14 up to Day 56 + 14) | 
| Percentage of Participants With Global Response Success 6 Weeks After End of Treatment | Global response based on combination of clinical and microbiological outcomes; success defined as clinical response of cure (resolution of signs and symptoms of Candida infection) or improvement (significant, but incomplete resolution of signs and symptoms of Candida infection) in conjunction with microbiological eradication (follow-up culture negative for Candida species) or presumed eradication (follow-up culture not available and clinical response of success). | 6 weeks after End of Treatment (Day 14 + 42 up to Day 56 + 42) | 
| Time to First Negative Blood Culture | Negative blood culture defined as first negative culture that was not followed by a positive culture within the next 3 days (or 4 days if negative culture was observed on or after Day 10) from start of study medication until end of intravenous treatment (EOIVT). Time to first negative culture includes the first day of study medication. | Day 1 up to Day 42 | 
| Day 90 Survival | Percentage of participants known or assumed to be alive on Day 90. | Day 90 | 
| Time to Successful Intensive Care Unit (ICU) Discharge | Time from start of study medication to successful ICU discharge (by end of treatment [EOT]), defined as being alive on the day after the EOT visit, not being in the ICU on the day after the EOT visit, and being classed as a global treatment success at EOT. | Day 1 up to Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candida, Candidemia, Systemic Candidiasis, ICU, Intensive Care Unit, Critical Care Unit, Anidulafungin, Ecalta, Eraxis, Fluconazole, Voriconazole