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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
41
Subjects in this arm will receive active anidulafungin and placebo caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin
Pfizer Investigational Site
Newark, Delaware, United States
Pfizer Investigational Site
Newark, Delaware, United States
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.
Time frame: End of Treatment (Day 14 to Day 42)
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.
Time frame: 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.
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Pfizer Investigational Site
Wilmington, Delaware, United States
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Antwerp, Belgium
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Brussels, Belgium
Pfizer Investigational Site
Sofia, Bulgaria
Pfizer Investigational Site
Vancouver, British Columbia, Canada
...and 8 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 6-week follow-up (6 weeks after EOT)