Clinical trial NCT00496197: Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
Official title: Phase IV Open Label Non Comparative Trial Of IV Anidulafungin Followed By Oral Azole Therapy For The Treatment Of Candidemia And Invasive Candidiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Candidiasis
Keywords: candidemia
invasive candidiasis
fungal bloodstream infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-04
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to further evaluate the safety and effectiveness of intravenous anidulafungin (Eraxis™) in patients with a diagnosis of candidemia or invasive candidiasis, which is a fungus infection of the blood or tissue. Currently the drug is approved for treatment using a daily dose of IV medication until 14 days after the fungus disappears from the blood. This study will evaluate the effectiveness of intravenous anidulafungin when it is administered for 5-28 days followed by oral antifungal medication. Study patients will be assessed for response to treatment throughout the study drug treatment period.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects \> or equal to 18 years of age.
* Presence of candidemia (positive blood culture) or invasive candidiasis (histopathologic or cytopathologic examination of a needle aspiration or biopsy specimen from a normally sterile site excluding mucous membranes showing yeast cells) obtained within the prior 96 hours of the screening visit.
* Subjects who received no more than one prior dose of an echinocandin or polyene.

Exclusion Criteria:

* Subjects with hypersensitivity to anidulafungin, other echinocandins or azoles.
* Presence of confirmed or suspected Candida osteomyelitis, endocarditis or meningitis.
* Subjects with infected prosthetic devices which cannot be removed within 24 hours

Primary outcomes:
measure: Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
timeFrame: End of Treatment (Day 5 up to Day 42)
Secondary outcomes:
measure: Number of Participants With Clinical Response at EOT
timeFrame: End of Treatment (Day 5 up to Day 42)
measure: Number of Participants With Microbiological Response at EOT
timeFrame: End of Treatment (Day 5 up to Day 42)
measure: Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)
timeFrame: End of Intravenous treatment (Day 5 up to Day 28)
measure: Number of Participants With Clinical Response at EOIV
timeFrame: End of Intravenous treatment (Day 5 up to Day 28)
measure: Number of Participants With Microbiological Response at EOIV
timeFrame: End of Intravenous treatment (Day 5 up to Day 28)
measure: Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up
timeFrame: Week 2 Follow-up
measure: Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
timeFrame: Week 2 follow-up
measure: Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
timeFrame: Week 2 Follow-up
measure: Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (End of Study [EOS])
timeFrame: Week 6 Follow-up (EOS)
measure: Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
timeFrame: Week 6 follow-up (EOS)
measure: Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
timeFrame: Week 6 Follow-up (EOS)
measure: Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOT for Participants With Non-albicans Candida at Baseline
timeFrame: End of Treatment (Day 5 up to Day 42)
measure: Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at EOIV for Participants With Non-albicans Candida at Baseline
timeFrame: End of Intravenous treatment (Day 5 up to Day 28)
measure: Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up for Participants With Non-albicans Candida at Baseline
timeFrame: Week 2 Follow-up
measure: Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 6 Follow-up (EOS) for Participants With Non-albicans Candida at Baseline
timeFrame: Week 6 Follow-up (EOS)
measure: Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species
timeFrame: Baseline (Day 1) up to Week 6 Follow-up (EOS)
measure: Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)
timeFrame: Baseline up to 6 Week Follow-up (EOS)
measure: Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)
timeFrame: Baseline up to 6 Week Follow-up (EOS)
measure: Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)
timeFrame: Baseline up to End of Intravenous treatment (Day 5 up to Day 28)
measure: Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)
timeFrame: Baseline up to End of Treatment (Day 5 up to Day 42)
measure: Number of Participants Per Specified Cause of Death
timeFrame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
measure: Number of Participants With Non-serious and Serious Adverse Events
timeFrame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
measure: Number of Participants Who Died
timeFrame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Birmingham
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Little Rock
country: United States
facility: Pfizer Investigational Site
state: Arkansas
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Newark
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Wilmington
country: United States
facility: Pfizer Investigational Site
state: Delaware
city: Washington
country: United States
facility: Pfizer Investigational Site
state: District of Columbia
city: Jacksonville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Orlando
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Detroit
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Royal Oak
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Minnesota
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Butte
country: United States
facility: Pfizer Investigational Site
state: Montana
city: Camden
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Albany
country: United States
facility: Pfizer Investigational Site
state: New York
city: Buffalo
country: United States
facility: Pfizer Investigational Site
state: New York
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Greenville
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: West Reading
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: De Rosa FG, Busca A, Capparella MR, Yan JL, Aram JA. Invasive Candidiasis in Patients with Solid Tumors Treated with Anidulafungin: A Post Hoc Analysis of Efficacy and Safety of Six Pooled Studies. Clin Drug Investig. 2021 Jun;41(6):539-548. doi: 10.1007/s40261-021-01024-7. Epub 2021 Apr 23.
citation: Sganga G, Wang M, Capparella MR, Tawadrous M, Yan JL, Aram JA, Montravers P. Evaluation of anidulafungin in the treatment of intra-abdominal candidiasis: a pooled analysis of patient-level data from 5 prospective studies. Eur J Clin Microbiol Infect Dis. 2019 Oct;38(10):1849-1856. doi: 10.1007/s10096-019-03617-9. Epub 2019 Jul 6.
citation: Kontoyiannis DP, Bassetti M, Nucci M, Capparella MR, Yan JL, Aram J, Hogan PA. Anidulafungin for the treatment of candidaemia caused by Candida parapsilosis: Analysis of pooled data from six prospective clinical studies. Mycoses. 2017 Oct;60(10):663-667. doi: 10.1111/myc.12641. Epub 2017 Jun 9.
citation: Kullberg BJ, Vasquez J, Mootsikapun P, Nucci M, Paiva JA, Garbino J, Yan JL, Aram J, Capparella MR, Conte U, Schlamm H, Swanson R, Herbrecht R. Efficacy of anidulafungin in 539 patients with invasive candidiasis: a patient-level pooled analysis of six clinical trials. J Antimicrob Chemother. 2017 Aug 1;72(8):2368-2377. doi: 10.1093/jac/dkx116.
citation: Vazquez J, Reboli AC, Pappas PG, Patterson TF, Reinhardt J, Chin-Hong P, Tobin E, Kett DH, Biswas P, Swanson R. Evaluation of an early step-down strategy from intravenous anidulafungin to oral azole therapy for the treatment of candidemia and other forms of invasive candidiasis: results from an open-label trial. BMC Infect Dis. 2014 Feb 21;14:97. doi: 10.1186/1471-2334-14-97.