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

Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00805740
• Other study ID #: A8851022
• Status: Terminated
• Phase: Phase 3
• First received: November 26, 2008
• Last updated: May 30, 2013
• Start date: April 2009
• Est. completion date: June 2012

Study information

• Verified date: May 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidiasis
• Fungemia

Intervention

Drug:
• Active anidulafungin
Subjects in this arm will receive active anidulafungin and placebo caspofungin
• Active Caspofungin
Subjects in this arm will receive active caspofungin and placebo anidulafungin

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Antwerpen
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Bruxelles
Bulgaria	Pfizer Investigational Site	Sofia
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Amsterdam
Netherlands	Pfizer Investigational Site	Nijmegen
Portugal	Pfizer Investigational Site	Coimbra
Portugal	Pfizer Investigational Site	Lisboa
Romania	Pfizer Investigational Site	Bucuresti
Russian Federation	Pfizer Investigational Site	P/o Stepanovskoe, Krasnogorskiy District, Moscow Region
Switzerland	Pfizer Investigational Site	Geneve 14
United States	Pfizer Investigational Site	Detroit	Michigan
United States	Pfizer Investigational Site	Newark	Delaware
United States	Pfizer Investigational Site	Newark	Delaware
United States	Pfizer Investigational Site	Wilmington	Delaware

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Netherlands,  Portugal,  Romania,  Russian Federation,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	Yes
Secondary	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)	Yes

External Links

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