Phase 4
N=282
Study Will Evaluate The Safety And Efficacy Of Anidulafungin In Patients With Candidemia Or Invasive Candidiasis
Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT00496197 ↗Enrolled (actual)
282
Serious AEs
47.5%
Results posted
Oct 2011
Primary outcome: Primary: Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT) — 170; 33 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Eraxis (anidulafungin) (Drug); Diflucan (fluconazole) (Drug); Vfend (voriconazole) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Treatment (EOT) |
170; 33 | — |
| SECONDARY Number of Participants With Clinical Response at EOT |
160; 14; 13 | — |
| SECONDARY Number of Participants With Microbiological Response at EOT |
124; 59; 6; 3 | — |
| SECONDARY Number of Participants With Global Response of Success or Failure (Based on Clinical and Microbiological Response) at End of Intravenous Treatment (EOIV) |
208; 27 | — |
| SECONDARY Number of Participants With Clinical Response at EOIV |
159; 57; 16 | — |
| SECONDARY Number of Participants With Microbiological Response at EOIV |
163; 61; 15; 3 | — |
| SECONDARY Number of Participants With Sustained (Continued) Global Response of Success or Failure (Based on Clinical and Microbiological Response) at Week 2 Follow-up |
148; 46 | — |
| SECONDARY Number of Participants With Sustained (Continued) Clinical Response at Week 2 Follow-up |
155; 9; 9 | — |
| SECONDARY Number of Participants With Sustained (Continued) Microbiological Response at Week 2 Follow-up |
30; 135; 3; 5 | — |
| SECONDARY 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]) |
131; 56 | — |
| SECONDARY Number of Participants With Sustained (Continued) Clinical Response at Week 6 Follow-up (EOS) |
138; 8; 10 | — |
| SECONDARY Number of Participants With Sustained (Continued) Microbiological Response at Week 6 Follow-up (EOS) |
12; 134; 2; 8 | — |
| SECONDARY 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 |
99; 21 | — |
| SECONDARY 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 |
119; 20 | — |
| SECONDARY 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 |
89; 27 | — |
| SECONDARY 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 |
75; 36 | — |
| SECONDARY Time (75% Quartile Point Estimate) to Negative Blood and / or Tissue Culture for Candida Species |
3.0000 | — |
| SECONDARY Medical Resource Utilization (MRU): Duration of Hospital Stay (Days) |
27.3; 27.1 | — |
| SECONDARY Medical Resource Utilization (MRU): Duration of Intensive Care Unit or Critical Care Unit Stay (Days) |
18.4 | — |
| SECONDARY Medical Resource Utilization (MRU): Duration of Intravenous Therapy (Days) |
8.9 | — |
| SECONDARY Medical Resource Utilization (MRU): Duration of Overall Therapy (Days) |
14.1 | — |
| SECONDARY Number of Participants Per Specified Cause of Death |
1; 1; 1; 2; 1; 1 | — |
| SECONDARY Number of Participants With Non-serious and Serious Adverse Events |
216; 134 | — |
| SECONDARY Number of Participants Who Died |
65 | — |
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
Data sourced from ClinicalTrials.gov (NCT00496197). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.