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

Last updated: October 6, 2015
Sponsor: Pfizer
Overall Status: Terminated

Phase

3

Condition

Yeast Infections

Systemic Fungal Infections

Vaginal Infection

Treatment

N/A

Clinical Study ID

NCT01176058
A8851023
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Presence of candidemia or invasive candidiasis.

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

Exclusion

Exclusion Criteria:

  • Subjects who received greater than 48 hours of systemic antifungal treatment for theCandida infection for which they will be enrolled.

  • Subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.

Study Design

Total Participants: 17
Study Start date:
December 01, 2010
Estimated Completion Date:
November 30, 2011

Study 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.

Connect with a study center

  • Nanfang Hospital

    Guangzhou, Guangdong 510515
    China

    Site Not Available

  • Nanjing General Hospital of Nanjing Military Command/Respiratory Department

    Nanjing, Jiangsu 210002
    China

    Site Not Available

  • Changhai Hospital, Hemotology Department

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • West China Hospital of Sichuan University/Center of Infectious Diseases

    Chengdu, Sichuan 610041
    China

    Site Not Available

  • Sir run run shaw hospital, Affiliated with school of medicine, Zhejiang University

    Hangzhou, Zhejiang 310016
    China

    Site Not Available

  • The First Affiliated Hospital of Medical School of Zhejiang University/Department of Hematology

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Peking Union Medical College Hospital / Department of Infectious Disease

    Beijing, 100730
    China

    Site Not Available

  • the Second Affiliate Hospital of the Third Military Medical University

    Chongqing, 400037
    China

    Site Not Available

  • Institute of Antibiotics, Hua Shan Hospital, Fudan University

    Shanghai, 200040
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, 110001
    China

    Site Not Available

  • Institute of Haematology and Blood Disease Hospital, Chinese Academy of Medical Science & PUMC

    Tianjin, 300020
    China

    Site Not Available

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