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

NCT01176058

Last updated date
Study Location
Nanfang Hospital
Guangzhou, Guangdong, 510515, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Candidemia
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Presence of candidemia or invasive candidiasis.

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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  5. Oakland, California
  6. Orange, California
  7. Orange, California
  8. Miami, Florida
  9. Durham, North Carolina
  10. Cleveland, Ohio
  11. Memphis, Tennessee
  12. Memphis, Tennessee
  13. Memphis, Tennessee
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  15. Memphis, Tennessee
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  17. Memphis, Tennessee
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  24. Milwaukee, Wisconsin
  25. Curitiba, Paraná
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Advanced Information
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 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
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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Arms  ICMJE 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
Actual Enrollment  ICMJE
 (submitted: January 12, 2012)
17
Original Estimated Enrollment  ICMJE
 (submitted: August 3, 2010)
364
Actual Study Completion Date  ICMJE November 2011
Actual 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01176058
Other Study ID Numbers  ICMJE A8851023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date August 2015

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