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

Pfizer logo

Pfizer

Status and phase

Terminated
Phase 3

Conditions

Fungemia
Candidiasis

Treatments

Drug: Active Caspofungin
Drug: Active anidulafungin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00805740
A8851022

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

41 participants in 2 patient groups

Anidulafungin arm
Experimental group
Treatment:
Drug: Active anidulafungin
Caspofungin arm
Experimental group
Treatment:
Drug: Active Caspofungin

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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