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

Phase 3

Terminated

• Conditions: Candidiasis; Fungemia
• Interventions: Drug: Active Caspofungin; Drug: Active anidulafungin

• Registration Number: NCT00805740
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-26
• Study First Submitted QC: 2008-12-09
• Study First Posted: 2008-12-10
• Study Start: 2009-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-05
• Results First Submitted: 2013-05-30
• Results First Submitted QC: 2013-05-30
• Last Update Submitted: 2013-05-30
• Results First Posted: 2013-08-01
• Last Update Posted: 2013-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caspofungin arm	Active Caspofungin	-
Anidulafungin arm	Active anidulafungin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Global Response at 2-week and 6-week Follow-up Visit	2-week follow-up (2 weeks after end of treatment [EOT]), 6-week follow-up (6 weeks after EOT)	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.
Percentage of Participants With Response Based on Clinical Cure and Microbiological Success	EOT (Day 14 to 42), 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)	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.
Percentage of Participants With Clinical Response	Day 10	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.
Percentage of Participants With Relapse	2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)	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.
Percentage of Participants With New Infection	2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)	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 to Negative Blood Culture	Baseline up to 6-week follow-up (6 weeks after EOT)	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.
Percentage of Participants With All-cause Mortality	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)	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 to Death	Baseline up to 6-week follow-up (6 weeks after EOT)	Time to death (days) was assessed as date of death minus first treatment date plus 1.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇭 Geneve 14, Switzerland