A Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Candidemia

Treatments: Drug: Anidulafungin/Fluconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01176058

A8851023

Details and patient eligibility

About

In the treatment of patients with candidemia and/or other forms of invasive candidiasis , Anidulafungin is at least as effective and safe as Fluconazole.

Full description

To support anidulafungin NDA in China Due to the challenges in subject recruitment resulting in protracted study course, Pfizer Inc. has decided to terminate trial A8851023 prematurely based on the recommendation by the senior management team on November 8, 2011. The decision to terminate the trial was not based on any safety concerns. All investigators were verbally informed by the study team since November 8, 2011 to stop the subject recruitment as soon as possible. All 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of candidemia or invasive candidiasis.
• Presence of one or more of signs and symptoms of acute fungal infection.

Exclusion criteria

• Subjects who received greater than 48 hours of systemic antifungal treatment for the Candida infection for which they will be enrolled.
• Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.

Trial design

17 participants in 1 patient group

open label

Active Comparator group

Treatment:

Drug: Anidulafungin/Fluconazole