Phase 3
N=43
Anidulafungin In Treatment Of Candidemia In Asian Subjects
Candidemia
Bottom Line
View on ClinicalTrials.gov: NCT00537329 ↗Enrolled (actual)
43
Serious AEs
37.2%
Results posted
Feb 2010
Primary outcome: Primary: Number of Subjects With Global Response of Success at End of Treatment — 31 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Anidulafungin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Global Response of Success at End of Treatment |
31 | — |
| SECONDARY Number of Subjects With Global Response of Success at Endpoints |
33; 24; 17; 16 | — |
| SECONDARY Number of Subjects With Clinical Response of Success at Endpoints |
34; 27; 7; 32; 27; 5 | — |
| SECONDARY Number of Subjects With Microbiological Response of Success at Endpoints |
36; 31; 5; 34; 31; 3 | — |
| SECONDARY Time to Death From Any Cause |
— | — |
| SECONDARY Time to Death Due to Candidemia |
— | — |
| SECONDARY Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment |
1095.8; 1447.9; 1183.9; 1132.0; 2753.3; 1312.1 | — |
| SECONDARY Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Clinical Response Status of Success or Status of Failure at End of All Treatment |
-0.4; -11.0; -1.7; -1.0; 1.3; -0.6 | — |
| SECONDARY Absolute Values for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response Status of Success or Status of Failure at End of All Treatment |
1219.7; 1040.4; 1183.9; 1349.0; 1017.4; 1312.1 | — |
| SECONDARY Change From Baseline for β-D-glucan Assay Results at Endpoints in Relation to Microbiological Response of Status of Success or Status of Failure at EOT |
0.0; -14.3; -1.7; 0.4; -5.2; -0.6 | — |
| SECONDARY Number of Subjects With Global Response of Success at EOT in Relation to Subject Subgroups |
1; 28; 10; 4; 4; 1 | — |
Summary
The purpose of this study is to determine whether or not the Investigational Study Drug anidulafungin is safe and effective in the treatment of a fungal infection, candidemia, in Asian subjects.
Eligibility Criteria
Inclusion Criteria
- Subjects with at least one positive blood test for Candida pathogen from a blood sample taken within 96 hours prior to start of study treatment.
- Subjects with clinical evidence of candida infection within 48 hours prior to enrollment.
- Acute Physiology and Chronic Health Enquiry (APACHE) score less than or equal to 20.
Exclusion Criteria
- Prior exposure to systemic antifungals for more than 48 hours.
- Subjects who had, at any time, previously received anidulafungin.
- Subjects with poor venous (vein) access that would inhibit the administration of the intravenous study drug or withdrawing of multiple blood samples.
- Life expectancy < 72 hours.
Data sourced from ClinicalTrials.gov (NCT00537329). 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.