An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System

Efficacy And Safety Of Eraxis/Ecalta (Anidulafungin) Compared To Cancidas (Caspofungin) In Neutropenic Patients With Invasive Candida 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 Candida infection in patients with an abnormal immune system. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Overall Status Terminated
Start Date August 2009
Completion Date October 2011
Primary Completion Date October 2011
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Global Response at End of Intravenous Treatment (EOIVT) Day 10 up to Day 42
Secondary Outcome
Measure Time Frame
Global Response at End of Treatment (EOT) Day 14 up to Day 56
Global Response at 2-Week Follow-Up Visit 2 weeks post treatment
Global Response at 6-Week Follow-Up Visit 6 weeks post treatment
Response Based on Clinical Cure and Microbiological Success at EOIVT Day 10 up to Day 42
Response Based on Clinical Cure and Microbiological Success at EOT Day 14 up to Day 56
Response Based on Clinical Cure and Microbiological Success at 2-Week Follow-Up Visit 2 weeks post treatment
Response Based on Clinical Cure and Microbiological Success at 6-Week Follow-Up Visit 6 weeks post treatment
Clinical Response at Day 10 Day 10
Number of Participants With Recurrence 2 and 6 weeks post treatment
Number of Participants With New Infections 2 and 6 weeks post treatment
Time to First Negative Blood Culture for Candida Species Baseline up to Day 56
Time to Death Day 1 up to Day 98
All-Cause Mortality Baseline up to 6 weeks post treatment
Enrollment 21
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:

- Dysfunctional immune system (reduced neutrophils).

- Confirmed Candida infection, defined as growth of Candida from a normally sterile site accompanied by signs and symptoms of infection.

- Male of female ≥16 years of age.

- Expected hospitalization for at least ten (10) 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 | Sarajevo, 71000, Bosnia and Herzegovina
Pfizer Investigational Site | GRENOBLE Cedex 09, 38043, France
Pfizer Investigational Site | Strasbourg Cedex, 67098, France
Pfizer Investigational Site | Bologna, 40138, Italy
Pfizer Investigational Site | Roma, 00133, Italy
Pfizer Investigational Site | Gdansk, 80-952, Poland
Pfizer Investigational Site | Warszawa, 02-776, Poland
Pfizer Investigational Site | Wroclaw, 50-367, Poland
Pfizer Investigational Site | Moscow, 115478, Russian Federation
Pfizer Investigational Site | Kosice, 04190, Slovakia
Location Countries

Bosnia and Herzegovina

France

Italy

Poland

Russian Federation

Slovakia

Verification Date

November 2012

Responsible Party

Type: Sponsor

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

Label: Anidulafungin Arm

Type: Experimental

Description: Subjects were randomized 2:1 (anidulafungin:caspofunin).

Label: Caspofungin Arm

Type: Experimental

Description: Subjects were randomized 2:1 (anidulafungin:caspofunin).

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov