CandidiasisPhase 4NCT00496197
Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
A Phase 4 study testing Eraxis (anidulafungin), Diflucan (fluconazole) and Vfend (voriconazole) in people with Candidiasis, run by Pfizer at 43 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidiasis
- What is being tested?
- Eraxis (anidulafungin), Diflucan (fluconazole) and Vfend (voriconazole)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 43 sitesin 2 countries
- Study dates
- Jul 2007to Jun 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
43 sites in 2 countries.
43 sites in 2 countries
United States39 sites
Pfizer Investigational Site
Albany, New York, 12208
Pfizer Investigational Site
Atlanta, Georgia, 30322
Pfizer Investigational Site
Baltimore, Maryland, 21205
Pfizer Investigational Site
Baltimore, Maryland, 21287
Pfizer Investigational Site
Birmingham, Alabama, 35233
Pfizer Investigational Site
Birmingham, Alabama, 35294
Pfizer Investigational Site
Buffalo, New York, 14263
Pfizer Investigational Site
Butte, Montana, 59701
Pfizer Investigational Site
Camden, New Jersey, 08103
Pfizer Investigational Site
Charleston, South Carolina, 29414
Pfizer Investigational Site
Detroit, Michigan, 48201
Pfizer Investigational Site
Detroit, Michigan, 48202
Pfizer Investigational Site
Greenville, North Carolina, 27834-6028
Pfizer Investigational Site
Greenville, North Carolina, 27834
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Jacksonville, Florida, 32209
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Los Angeles, California, 90033
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
Minneota, Minnesota, 55455
Pfizer Investigational Site
Newark, Delaware, 19713
Pfizer Investigational Site
Newark, Delaware, 19718
Pfizer Investigational Site
Orlando, Florida, 32801
Pfizer Investigational Site
Orlando, Florida, 32806
Pfizer Investigational Site
Orlando, Florida, 32819
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19140
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15213
Pfizer Investigational Site
Portland, Oregon, 97239
Pfizer Investigational Site
Rochester, New York, 14642
Pfizer Investigational Site
Royal Oak, Michigan, 48073
Pfizer Investigational Site
San Francisco, California, 94115
Pfizer Investigational Site
San Francisco, California, 94143
Pfizer Investigational Site
Springfield, Illinois, 62701
Pfizer Investigational Site
Springfield, Illinois, 62702
Pfizer Investigational Site
Springfield, Illinois, 62703-9248
Pfizer Investigational Site
Springfield, Illinois, 62703
Pfizer Investigational Site
Washington D.C., District of Columbia, 20010
Pfizer Investigational Site
West Reading, Pennsylvania, 19611
Pfizer Investigational Site
Wilmington, Delaware, 19801
South Korea4 sites
Pfizer Investigational Site
Seoul, 120-752
Pfizer Investigational Site
Seoul, 135-710
Pfizer Investigational Site
Seoul, 137-701
Pfizer Investigational Site
Seoul, 138-736
About this study
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
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.
- Conditions
- Candidiasis
- Being tested
- Eraxis (anidulafungin), Diflucan (fluconazole), Vfend (voriconazole)
- Keywords
- candidemia, invasive candidiasis, fungal bloodstream infection
- Medical subject headings
- Candidiasis, Candidemia, Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eraxis (anidulafungin)Drug
Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
Diflucan (fluconazole)Drug
Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis.
Vfend (voriconazole)Drug
Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species.
| Study group | Role | What they receive |
|---|---|---|
| 1. | Experimental | Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole. Receives: Drug: Eraxis (anidulafungin); Drug: Diflucan (fluconazole); Drug: Vfend (voriconazole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: End of Treatment (Day 5 up to Day 42)
Secondary outcomes (23)
Number of Participants With Clinical Response at EOT
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Measured: End of Treatment (Day 5 up to Day 42)
Number of Participants With Microbiological Response at EOT
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Measured: End of Treatment (Day 5 up to Day 42)
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: End of Intravenous treatment (Day 5 up to Day 28)
Number of Participants With Clinical Response at EOIV
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Measured: End of Intravenous treatment (Day 5 up to Day 28)
Number of Participants With Microbiological Response at EOIV
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Measured: End of Intravenous treatment (Day 5 up to Day 28)
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: Week 2 Follow-up
Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Measured: Week 2 follow-up
Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Measured: Week 2 Follow-up
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])
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: Week 6 Follow-up (EOS)
Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
Clinical Success=Cure: resolution of Candida s/s or Improvement: significant but incomplete resolution of s/s; Clinical Failure: at least 3 doses Anidulafungin with no significant improvement in s/s or death due to Candida.
Measured: Week 6 follow-up (EOS)
Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
Microbiological Success=Eradication: negative culture for baseline Candida spp or Presumed Eradication: f/u culture n/a and clinical outcome defined as success (cure or improvement); Microbiological Failure=Persistence: positive culture for at least 1 baseline Candida spp or Presumed Persistence: f/u culture n/a and clinical outcome defined as failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida).
Measured: Week 6 Follow-up (EOS)
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
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: End of Treatment (Day 5 up to Day 42)
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
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: End of Intravenous treatment (Day 5 up to Day 28)
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
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: Week 2 Follow-up
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
Success: Clinical response=Cure (s/s of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (f/u culture negative) or Presumed Eradication (f/u culture n/a and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida spp) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
Measured: Week 6 Follow-up (EOS)
Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species
Participants with a negative culture on Day 1 were not included in the analysis. For participants with a positive culture on Day 1, the first day on which there was a negative culture was determined and then compared to the result of the next culture. If the next culture was also negative, or the next culture was positive but the interval between the 2 cultures was > 3 days, the earlier of the 2 cultures was the day of first negative blood culture. If next culture was positive and taken within 3 days of the previous culture, the process was repeated with the next negative blood culture.
Measured: Baseline (Day 1) up to Week 6 Follow-up (EOS)
Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)
Measured as time to dischargeable (medically dischargeable status) and as time to discharge (actual discharge). Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Measured: Baseline up to 6 Week Follow-up (EOS)
Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)
Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Measured: Baseline up to 6 Week Follow-up (EOS)
Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)
Analysis of length of hospital stay based on Kaplan-Meier survival techniques.
Measured: Baseline up to End of Intravenous treatment (Day 5 up to Day 28)
Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)
Overall therapy includes Intravenous and Oral therapy. Participants were to receive at least 5 days and a maximum of 28 days of IV anidulafungin. After that, participants could continue treatment with oral fluconazole or voriconazole for at least 14 days from the day of last positive culture.
Measured: Baseline up to End of Treatment (Day 5 up to Day 42)
Number of Participants Per Specified Cause of Death
Cause of death (includes all-cause and attributable to Candida infection) reported based on death due to Serious Adverse Events (SAEs). SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect. Participants may be counted with > 1 cause of death if multiple causes were present.
Measured: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
Number of Participants With Non-serious and Serious Adverse Events
AEs are any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. SAEs are any untoward medical occurrence at any dose that results in death, is life threatening, requires in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, results in congenital anomaly or birth defect.
Measured: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
Number of Participants Who Died
Measured: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CandidiasisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 282 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496197
- Sponsor's protocol ID
- A8851011
- Status last verified
- Aug 2011
- First submitted
- 3 Jul 2007
- Last updated
- 3 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 33891293Sganga 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.
PubMed 31280481Kontoyiannis 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.
PubMed 28597967Kullberg 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.
PubMed 28459966Vazquez 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.
PubMed 24559321
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00496197
- Acronym / sponsor ID
- A8851011
- Conditions
- Candidiasis
- Keywords
- candidemia, invasive candidiasis, fungal bloodstream infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 282 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 4 Jul 2007 (estimated)
- Results
- Posted 3 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | Experimental | Drug: Eraxis (anidulafungin), Drug: Diflucan (fluconazole), Drug: Vfend (voriconazole)Subjects receive anidulafungin IV followed by oral therapy with fluconazole or voriconazole. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eraxis (anidulafungin)Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species. | Drug | 1. |
| Diflucan (fluconazole)Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis. | Drug | 1. |
| Vfend (voriconazole)Subjects will receive IV anidulafungin (200 mg loading dose followed by 100 mg maintenance doses QD) for 5-28 days. This will be followed by oral therapy with fluconazole at 400 mg once daily or voriconazole at 200 mg twice daily until 14 days after the last positive culture. Fluconazole will be used if the baseline cultures are positive for C. albicans or C. parapsilosis while voriconazole will be used if cultures are positive for C. glabrata or other non-albicans species. | Drug | 1. |
Primary outcome
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT)
Time frame: End of Treatment (Day 5 up to Day 42)
Success: Clinical response=Cure (no signs, symptoms [s/s] of Candida) or Improvement (significant, incomplete resolution of s/s) and Microbiological response=Eradication (follow up [f/u] culture negative) or Presumed Eradication (f/u culture not available [n/a] and response of clinical success). Failure: Clinical response=Failure (≥3 doses Anidulafungin with no significant improvement in s/s or death due to Candida) and Microbiological response=Persistence (positive culture for ≥1 baseline Candida species [spp]) or Presumed Persistence (f/u culture n/a and clinical outcome= failure).
23 secondary outcomes
Number of Participants With Clinical Response at EOT
Time frame: End of Treatment (Day 5 up to Day 42)
Number of Participants With Microbiological Response at EOT
Time frame: End of Treatment (Day 5 up to Day 42)
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV)
Time frame: End of Intravenous treatment (Day 5 up to Day 28)
Number of Participants With Clinical Response at EOIV
Time frame: End of Intravenous treatment (Day 5 up to Day 28)
Number of Participants With Microbiological Response at EOIV
Time frame: End of Intravenous treatment (Day 5 up to Day 28)
Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up
Time frame: Week 2 Follow-up
Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up
Time frame: Week 2 follow-up
Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up
Time frame: Week 2 Follow-up
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])
Time frame: Week 6 Follow-up (EOS)
Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS)
Time frame: Week 6 follow-up (EOS)
Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS)
Time frame: Week 6 Follow-up (EOS)
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
Time frame: End of Treatment (Day 5 up to Day 42)
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
Time frame: End of Intravenous treatment (Day 5 up to Day 28)
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
Time frame: Week 2 Follow-up
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
Time frame: Week 6 Follow-up (EOS)
Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species
Time frame: Baseline (Day 1) up to Week 6 Follow-up (EOS)
Medical Resource Utilization (MRU): Duration of Hospital Stay (Days)
Time frame: Baseline up to 6 Week Follow-up (EOS)
Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days)
Time frame: Baseline up to 6 Week Follow-up (EOS)
Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days)
Time frame: Baseline up to End of Intravenous treatment (Day 5 up to Day 28)
Medical Resource Utilization (MRU): Duration of Overall Therapy (Days)
Time frame: Baseline up to End of Treatment (Day 5 up to Day 42)
Number of Participants Per Specified Cause of Death
Time frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
Number of Participants With Non-serious and Serious Adverse Events
Time frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
Number of Participants Who Died
Time frame: Baseline up to Week 6 Follow-up (EOS) or 30 days after last dose of study drug (whichever was later)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33891293De 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.
- Derived from this study: PubMed 31280481Sganga 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.
- Derived from this study: PubMed 28597967Kontoyiannis 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.
- Derived from this study: PubMed 28459966Kullberg 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.
- Derived from this study: PubMed 24559321Vazquez 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
43 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Eraxis (anidulafungin), Diflucan (fluconazole) and Vfend (voriconazole) in people with Candidiasis, run by Pfizer at 43 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT) (time frame: End of Treatment (Day 5 up to Day 42)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00496197, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2011.