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

This study has been terminated.

(See termination reason in detailed description.)

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01176058

First received: August 3, 2010

Last updated: January 12, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 3, 2010

Last Updated Date

January 12, 2012

Start Date ^ICMJE

December 2010

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The primary endpoint is Global Response (combined clinical and microbiological response) at End of Intravenous Treatment (EOIT) in subjects with confirmed candidemia and/or other forms of invasive candidiasis. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT01176058 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Global response at the end of all study treatment (intravenous and oral). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Clinical response at EOIT, EOT and follow-up visit [ Time Frame: 7 days, 6 weeks and 7 weeks ] [ Designated as safety issue: No ]
Microbiological response at EOIT, EOT and follow-up visit [ Time Frame: 7 days, 6 weeks and 7 weeks ] [ Designated as safety issue: No ]
Mortality [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Safety and tolerability of anidulafungin and fluconazole including adverse events and laboratory tests. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Global response at the end of all study treatment (intravenous and oral). [ Time Frame: the end of all study treatment ] [ Designated as safety issue: No ]
Clinical response at EOIT, EOT and follow-up visit [ Time Frame: EOIT,EOT, follow-up visit ] [ Designated as safety issue: No ]
Microbiological response at EOIT, EOT and follow-up visit [ Time Frame: EOIT,EOT, follow-up visit ] [ Designated as safety issue: No ]
Mortality [ Time Frame: the end of study ] [ Designated as safety issue: Yes ]
Safety and tolerability of anidulafungin and fluconazole including adverse events and laboratory tests. [ Time Frame: during study ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase 3b, Open-Label, Randomized, Multi-Center Study Of The Efficacy And Safety Of Anidulafungin Vs. Fluconazole In The Treatment Of Patients With Candidemia And/Or Other Forms Of Invasive Candidiasis

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Candidemia

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: open label

Intervention: Drug: Anidulafungin/Fluconazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

November 2011

Primary Completion Date

November 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01176058

Other Study ID Numbers ^ICMJE

A8851023

Has Data Monitoring Committee

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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