An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida

Study Overview
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Brief Summary
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The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Official Title
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Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Patients With Candida Deep Tissue Infection

Conditions
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Candidiasis, Fungemia

Intervention / Treatment
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* Drug: Active anidulafungin
* Drug: Active Caspofungin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of deep tissue Candida infection, defined as growth of Candida sp. from a culture specimen obtained from a normally sterile site accompanied by signs and symptoms of infection. Male or female ≥ 16 years of age. Expected hospitalization for at least fourteen (14) days. Exclusion Criteria: Pregnancy or breast feeding or planning to become pregnant during the study. Recent treatment with one of the study drugs over the last 30 days. Allergy to either study drug or to this class of drugs. Significant liver dysfunction. Suspected Candida osteomyelitis, endocarditis, meningitis or any other infections of the central nervous system.

Ages Eligible for Study
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Minimum Age: 16 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anidulafungin arm<br> | Drug: Active anidulafungin<br>* Subjects in this arm will receive active anidulafungin and placebo caspofungin<br>|
| Experimental: Caspofungin arm<br> | Drug: Active Caspofungin<br>* Subjects in this arm will receive active caspofungin and placebo anidulafungin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42) | Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome. | End of Treatment (Day 14 to Day 42) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit | Participants had successful global response if there was clinical response of cure/improvement,microbiological eradication/presumed eradication.Clinical cure:resolution of signs/symptoms (s/s) of Candida infection;no additional systemic/oral antifungal treatment needed.Clinical improvement:significant,but incomplete resolution of s/s of Candida infection;no additional systemic/oral antifungal treatment needed.Microbiological eradication/presumed eradication:baseline pathogen not isolated from original site culture,or culture data not available for participant with successful clinical outcome. | 2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT) | 
| Percentage of Participants With Response Based on Clinical Cure and Microbiological Success | A participant had a successful response if there was clinical response of cure and microbiological success (eradication or presumed eradication). Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Microbiological eradication or presumed eradication: baseline pathogen not isolated from original site culture, or culture data not available for a participant with successful clinical outcome. | EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) | 
| Percentage of Participants With Clinical Response | A participant had a successful clinical response if there was clinical response of cure or improvement. Clinical response of cure: resolution of signs and symptoms attributed to Candida infection; no additional systemic or oral antifungal treatment required to complete the course of therapy. Clinical response of improvement: significant, but incomplete resolution of signs and symptoms of Candida infection; no additional systemic or oral antifungal treatment required. | Day 10 | 
| Percentage of Participants With Relapse | Relapse was defined as any baseline Candida sp. isolated following eradication (documented or presumed) or culture data not available for participants with a clinical response of failure after a previous response of success. Prophylactic treatment with oral antifungal agents was not sufficient to document a relapse. | 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) | 
| Percentage of Participants With New Infection | New Infection: participant presenting with clinical failure with the emergence of new Candida sp. at the original site of infection or at a distant site of infection. Clinical failure: no significant improvement in signs and symptoms, or death due to Candida infection. Participants must have had received at least 3 doses of study drug to be classified as a failure. | 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT) | 
| Time to Negative Blood Culture | Negative blood culture referred to absence of Candida sp. in the blood sample of participants who had a positive blood culture at baseline. Time to negative blood culture (days) was calculated as date of first negative blood culture minus first treatment date plus 1. | Baseline up to 6-week follow-up (6 weeks after EOT) | 
| Percentage of Participants With All-cause Mortality | All-cause mortality during study therapy and at follow-up visits reported as unique death at EOT, 2 week follow-up and 6 week follow-up. | Baseline to EOT (Day 14 to 42), After EOT to 2-week follow-up (2 weeks after EOT), After 2-week follow-up to 6-week follow-up (6 weeks after EOT) | 
| Time to Death | Time to death (days) was assessed as date of death minus first treatment date plus 1. | Baseline up to 6-week follow-up (6 weeks after EOT) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection