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

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

Sponsors

Lead Sponsor: Pfizer

Source 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.

Overall Status Terminated
Start Date April 2009
Completion Date June 2012
Primary Completion Date June 2012
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Percentage of Participants With Global Response at End of Treatment (Day 14 To Day 42) End of Treatment (Day 14 to Day 42)
Secondary Outcome
Measure Time Frame
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)
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)
Percentage of Participants With Clinical Response Day 10
Percentage of Participants With Relapse 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Percentage of Participants With New Infection 2-week follow-up (2 weeks after EOT), 6-week follow-up (6 weeks after EOT)
Time to Negative Blood Culture Baseline up to 6-week follow-up (6 weeks after EOT)
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)
Time to Death Baseline up to 6-week follow-up (6 weeks after EOT)
Enrollment 41
Condition
Intervention

Intervention Type: Drug

Intervention Name: Active anidulafungin

Description: Subjects in this arm will receive active anidulafungin and placebo caspofungin

Arm Group Label: Anidulafungin arm

Intervention Type: Drug

Intervention Name: Active Caspofungin

Description: Subjects in this arm will receive active caspofungin and placebo anidulafungin

Arm Group Label: Caspofungin arm

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 16 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
Pfizer Investigational Site | Newark, Delaware, 19713, United States
Pfizer Investigational Site | Newark, Delaware, 19718, United States
Pfizer Investigational Site | Wilmington, Delaware, 19801, United States
Pfizer Investigational Site | Detroit, Michigan, 48202, United States
Pfizer Investigational Site | Antwerpen, 2060, Belgium
Pfizer Investigational Site | Bruxelles, 1000, Belgium
Pfizer Investigational Site | Bruxelles, 1070, Belgium
Pfizer Investigational Site | Bruxelles, 1200, Belgium
Pfizer Investigational Site | Sofia, 1606, Bulgaria
Pfizer Investigational Site | Vancouver, British Columbia, V6Z 1Y6, Canada
Pfizer Investigational Site | Amsterdam, 1081 HZ, Netherlands
Pfizer Investigational Site | Amsterdam, 1091 AC, Netherlands
Pfizer Investigational Site | Nijmegen, 6532 SZ, Netherlands
Pfizer Investigational Site | Coimbra, 3040-853, Portugal
Pfizer Investigational Site | Lisboa, 1150-199, Portugal
Pfizer Investigational Site | Bucuresti, 014461, Romania
Pfizer Investigational Site | P/o Stepanovskoe, Krasnogorskiy District, Moscow Region, 143423, Russian Federation
Pfizer Investigational Site | Geneve 14, CH-1211, Switzerland
Location Countries

Belgium

Bulgaria

Canada

Netherlands

Portugal

Romania

Russian Federation

Switzerland

United States

Verification Date

May 2013

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Anidulafungin arm

Type: Experimental

Label: Caspofungin arm

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov