NCT01176058

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

A Phase Iiib, Open-label, Randomized, Multi-center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole, In The Treatment Of Subjects With Candidemia And/or Other Forms Of Invasive Candidiasis

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Candidemia

Interventions

Type	Name	Description
DRUG	Anidulafungin/Fluconazole	Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-08-05
• Last updated: 2015-10-28
• Results posted: 2015-09-21

Locations

7 sites across 1 country: China