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

NCT00805740 | Terminated Phase 3 Results DMC

• 1 other identifier: A8851022
• Study Type: interventional
• Target: 41
• Locations: 9 countries
• Sites: 18

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.

Conditions

Candidiasis; Fungemia

Keywords

Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (8)

• 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)

Study Arms (2)

Anidulafungin arm

EXPERIMENTAL

Drug: Active anidulafungin

Caspofungin arm

EXPERIMENTAL

Drug: Active Caspofungin

Interventions

Active anidulafungin DRUG

Subjects in this arm will receive active anidulafungin and placebo caspofungin

Anidulafungin arm

Active Caspofungin DRUG

Subjects in this arm will receive active caspofungin and placebo anidulafungin

Caspofungin arm

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

Pfizer Investigational Site

Newark, Delaware, 19713, United States

Location

Pfizer Investigational Site

Newark, Delaware, 19718, United States

Location

Pfizer Investigational Site

Wilmington, Delaware, 19801, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 48202, United States

Location

Pfizer Investigational Site

Antwerp, 2060, Belgium

Location

Pfizer Investigational Site

Brussels, 1000, Belgium

Location

Pfizer Investigational Site

Brussels, 1070, Belgium

Location

Pfizer Investigational Site

Brussels, 1200, Belgium

Location

Pfizer Investigational Site

Sofia, 1606, Bulgaria

Location

Pfizer Investigational Site

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Pfizer Investigational Site

Amsterdam, 1081 HZ, Netherlands

Location

Pfizer Investigational Site

Amsterdam, 1091 AC, Netherlands

Location

Pfizer Investigational Site

Nijmegen, 6532 SZ, Netherlands

Location

Pfizer Investigational Site

Coimbra, 3040-853, Portugal

Location

Pfizer Investigational Site

Lisbon, 1150-199, Portugal

Location

Pfizer Investigational Site

Bucharest, 014461, Romania

Location

Pfizer Investigational Site

P/o Stepanovskoe, Krasnogorskiy District, Moscow Region, 143423, Russia

Location

Pfizer Investigational Site

Geneva, CH-1211, Switzerland

Location

Related Publications (4)

• De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.

  PMID: 33891293 DERIVED

• Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.

  PMID: 31280481 DERIVED

• Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.

  PMID: 28597967 DERIVED

• Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.

  PMID: 28459966 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Candidiasis; Fungemia; Candidiasis, Invasive; Torulopsis; Candidemia; Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The study was prematurely terminated due to slow enrollment. The study was not terminated due to any safety issues or concerns.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2008
• First Posted: December 10, 2008
• Study Start: April 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: August 1, 2013
• Results First Posted: August 1, 2013

Record last verified: 2013-05

Locations

PT (2); BU (1); BE (4); US (4); RO (1); NL (3); CH (1); CA (1); RU (1)