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

NCT00806351 | Terminated Phase 3 Results DMC

• 1 other identifier: A8851021
• Study Type: interventional
• Target: 21
• Locations: 6 countries
• Sites: 10

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.

Conditions

Fungemia; Neutropenia; Candidiasis

Keywords

Candidiasis; Invasive Candidiasis; Candida; Candidemia; Fungal Infection; Neutropenia

Outcome Measures

Primary Outcomes (1)

• Global Response at End of Intravenous Treatment (EOIVT)

  Participant counts of global response of success, failure, or indeterminate. Success: clinical response of cure (no signs, symptoms \[s/s\] of Candida) or improvement (significant, incomplete resolution of s/s) and microbiological response of eradication (follow-up \[f/u\] culture negative) or presumed eradication (f/u culture not available and clinical success). Failure: clinical response of failure (greater than or equal to \[≥3\] doses study medication and no significant improvement of s/s or death due to Candida) and/or unsuccessful microbiological response of persistent(positive culture any Candida species \[sp\]), new infection or relapse at f/u. Indeterminate: clinical and/or microbiological response of indeterminate (evaluation could not be made due to withdrawal from study prior to assessment of cure or failure) and there was neither clinical response of failure nor unsuccessful microbiological response (persistence or new infection or relapse).

  Day 10 up to Day 42

Secondary Outcomes (13)

• 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

Study Arms (2)

Anidulafungin Arm

EXPERIMENTAL

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

Drug: Active Anidulafungin

Caspofungin Arm

EXPERIMENTAL

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

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:

• 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.

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 (10)

Pfizer Investigational Site

Sarajevo, 71000, Bosnia and Herzegovina

Location

Pfizer Investigational Site

Grenoble, 38043, France

Location

Pfizer Investigational Site

Strasbourg, 67098, France

Location

Pfizer Investigational Site

Bologna, 40138, Italy

Location

Pfizer Investigational Site

Roma, 00133, Italy

Location

Pfizer Investigational Site

Gdansk, 80-952, Poland

Location

Pfizer Investigational Site

Warsaw, 02-776, Poland

Location

Pfizer Investigational Site

Wroclaw, 50-367, Poland

Location

Pfizer Investigational Site

Moscow, 115478, Russia

Location

Pfizer Investigational Site

Košice, 04190, Slovakia

Location

Related Publications (3)

• 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

• 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

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

Condition Hierarchy (Ancestors)

Invasive Fungal Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Limitations and Caveats

Study prematurely terminated due to slow enrollment, not due to safety issues. Meaningful interpretation and comparison of treatment outcomes with caspofungin was difficult due to low number of participants (n=3) with confirmed Candida infection.

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: August 1, 2009
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 20, 2012
• Results First Posted: December 20, 2012

Record last verified: 2012-11

Locations

SL (1); IT (2); PL (3); BO (1); RU (1); FR (2)