N/A
N=50
Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom
Candidiasis
Bottom Line
View on ClinicalTrials.gov: NCT01202253 ↗Enrolled (actual)
50
Serious AEs
10.0%
Results posted
Oct 2012
Primary outcome: Primary: Percentage of Participants With Favorable Outcome — 76.1 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- anidulafungin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Favorable Outcome |
76.1 | — |
| SECONDARY Percentage of Participants With Unfavorable Outcome |
23.9 | — |
| SECONDARY Percentage of Participants Who Died Due to All Causes |
38.0 | — |
| SECONDARY Percentage of Participants With Death Attributable to Fungal Infection |
— | — |
| SECONDARY Percentage of Participants With Death Unrelated to Fungal Infection |
36.0 | — |
| SECONDARY Percentage of Participants With Favorable Clinical Response |
80.4 | — |
| SECONDARY Percentage of Participants With Lack of Clinical Response |
19.6 | — |
| SECONDARY Percentage of Participants Requiring Change or Additional Antifungal Therapy |
16.0; 4.0; 0.0 | — |
| SECONDARY Percentage of Participants With Oral Antifungal Started to Complete Therapy |
32.0 | — |
| SECONDARY Percentage of Participants With Documented Eradication of Infecting Species |
— | — |
| SECONDARY Percentage of Participants With Resolution of Signs of Infection According to Ultrasound Scan Results |
80.0 | — |
| SECONDARY Percentage of Participants With Resolution of Signs of Infection According to Computerized Tomography (CT) Scan Results |
68.0 | — |
| SECONDARY Percentage of Participants With Abnormal Results for Liver Function at Initiation of Drug Therapy |
98.0 | — |
| SECONDARY Percentage of Participants With Abnormal Results for Liver Function at End of Drug Therapy |
74.0 | — |
| SECONDARY Percentage of Participants With Liver Function Test Results at Least Twice the Baseline Value During Period of Drug Therapy |
24.0; 40.0; 34.0; 36.0 | — |
| SECONDARY Percentage of Participants With Creatinine Clearance at Least Twice the Baseline Value During Period of Drug Therapy |
— | — |
| SECONDARY Percentage of Participants Admitted to Liver Intensive Therapy Unit (LITU) |
78.0 | — |
| SECONDARY Duration of Stay at Liver Intensive Therapy Unit (LITU) |
29.38 | — |
| SECONDARY Percentage of Participants With Absolute Neutrophil Count Less Than 500 Per Cubic Millimeter (/mm^3) and Greater Than or Equal to 500 /mm^3 |
2.0; 98.0 | — |
| SECONDARY Percentage of Participants With Concomitant Bacterial or Viral Infection |
96.0; 46.0 | — |
| SECONDARY Percentage of Participants Prescribed With Systemic Antifungal Within 30 Days Before Study Start |
4.0; 4.0; 70.0 | — |
| SECONDARY Dose Changes for Immunosuppressant Drugs |
— | — |
| SECONDARY Percentage of Participants With Probable or Proven Fungal Infection at the Initiation of Drug Therapy |
28.0; 72.0 | — |
| SECONDARY Percentage of Participants With Documented Body Temperature Above 38.0 Degree Celsius or Below 36.0 Degree Celsius Within 24 Hour Period Prior to Initiation of Drug Therapy |
98.0; 2.0 | — |
| SECONDARY Percentage of Participants With Systolic Blood Pressure More Than 2 Standard Deviations Below the Mean for Age Recorded Within 24 Hour Period Prior to Initiation of Drug Therapy |
4.0 | — |
| SECONDARY Number of Participants With Infection Sites as Per Microbiological Analysis |
4; 1; 2; 3; 13; 3 | — |
| SECONDARY Number of Participants With Infection Sites as Per Ultrasound Scan and Computerized Tomography (CT) Scan |
— | — |
| SECONDARY Infecting Organisms by Species |
17; 17; 3; 2; 3; 16 | — |
| SECONDARY Percentage of Participants With Prior Colonization With Candida by Species |
16.0; 10.0; 2.0; 12.0; 2.0; 6.0 | — |
| SECONDARY Percentage of Participants With Prior Colonization With Candida by Colonization Index |
— | — |
| SECONDARY Percentage of Participants With Other Prior Fungal Infection by Species and Colonization Index |
— | — |
| SECONDARY Number of Participants Who Received Water-based and Ethanol-based Formulation |
16; 34 | — |
| SECONDARY Percentage of Participants Who Received Water-based and Ethanol-based Formulation |
32.0; 68.0 | — |
| SECONDARY Percentage of Participants Who Received 200 mg Loading Dose |
100.0 | — |
| SECONDARY Percentage of Participants Who Received 100 mg Dose on Day 2 |
100.0 | — |
| SECONDARY Percentage of Participants Who Received 200 mg Dose on Day 1 and 100 mg for All Subsequent Doses |
100.0 | — |
| SECONDARY Number of Participants With Other Dosing Patterns |
— | — |
| SECONDARY Duration of Anidulafungin Therapy |
17.96 | — |
| SECONDARY Number of Serious Adverse Events (SAEs) |
5 | — |
| SECONDARY Percentage of Participants With One or More Drug-related Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Number of Participants With Different Types of Drug-related Serious Adverse Events |
— | — |
Summary
The purpose of this study is to describe the real world effectiveness of anidulafungin in clinical practice in a large Liver Unit in the United Kingdom.
Eligibility Criteria
Inclusion Criteria
- Subjects who have been prescribed anidulafungin between 1st July 2009 and 30th September 2010.
Patients admitted to specialist liver unit wards and the Liver Intensive Therapy Unit during this period
Exclusion Criteria
- Patients who participated in any interventional clinical trial during this episode of sepsis.
Patients who received anidulafungin for infection prophylaxis
Data sourced from ClinicalTrials.gov (NCT01202253). 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.