Phase 3
Completed N=216
Anidulafungin Candidemia/Invasive Candidiasis Intensive Care Study
Source: ClinicalTrials.gov NCT00689338 ↗Enrolled (actual)
216
Serious AEs
49.5%
Results posted
May 2011
Primary outcomePrimary: Percentage of Participants With Global Treatment Response Success at End of Treatment — 69.5 percentage of participants
Summary
To evaluate the efficacy and safety of anidulafungin in the treatment of systemic fungal infections in intensive care and critical care unit patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Global Treatment Response Success at End of Treatment |
69.5 | — |
| SECONDARY Percentage of Participants With Global Response Success at End of Intravenous Treatment (EOIVT) |
70.7 | — |
| SECONDARY Percentage of Participants With Global Response Success at 2 Weeks After End of Treatment |
60.2 | — |
| SECONDARY Percentage of Participants With Global Response Success 6 Weeks After End of Treatment |
50.5 | — |
| SECONDARY Time to First Negative Blood Culture |
3.7 | — |
| SECONDARY Day 90 Survival |
54.1 | — |
| SECONDARY Time to Successful Intensive Care Unit (ICU) Discharge |
16.2 | — |
Eligibility Criteria
Inclusion Criteria
ICU patients with a diagnosis of documented candidemia or invasive candidiasis and belonging to one or more of the following specific populations:
- Post-abdominal surgery.
- Elderly > 65 years old.
- Renal insufficiency / failure / hemodialysis.
- Solid tumor.
- Solid-organ (liver, kidney, lung, heart) transplant recipients.
- Hepatic insufficiency.
- Neutropenic including hematology oncology patients.
Exclusion Criteria
Patients with poor venous access that would preclude IV drug delivery or multiple blood draws.
Data sourced from ClinicalTrials.gov (NCT00689338). 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. Informational only — not medical advice.