Early Clinical Experience With Anidulafungin In Patients With Liver Disease In The United Kingdom

NCT01202253 | Completed Results

• 1 other identifier: A8851028
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Candidiasis

Keywords

Ecalta; Eraxis; Candida; Candidemia; Systemic Candidiasis; ICU; Intensive Care Unit; Critical Care Unit

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Favorable Outcome

  Favorable outcome was defined as favorable clinical response and documented or presumed microbial eradication (two negative follow-up blood cultures for bloodstream infections or a successful clinical response without follow-up cultures for other infections). Favorable clinical response was defined as clinical resolution of signs and symptoms of infection and no need to change or add to antifungal therapy, or transition to oral antifungal to complete therapy.

  Day 28 post-treatment

Secondary Outcomes (40)

• Percentage of Participants With Unfavorable Outcome

  Day 28 post-treatment

• Percentage of Participants Who Died Due to All Causes

  Baseline up to Day 28 post-treatment

• Percentage of Participants With Death Attributable to Fungal Infection

  Baseline up to Day 28 post-treatment

• Percentage of Participants With Death Unrelated to Fungal Infection

  Baseline up to Day 28 post-treatment

• Percentage of Participants With Favorable Clinical Response

  Day 28 post-treatment

Study Arms (1)

Anidulafungin

Drug: anidulafungin

Interventions

anidulafungin DRUG

A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.

Also known as: ECALTA, ERAXIS

Anidulafungin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects admitted with candidiasis infections to the Liver Unit at King's College Hospital (United Kingdom) who are prescribed anidulafungin.

You may qualify if:

• 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

You may not qualify if:

• Patients who participated in any interventional clinical trial during this episode of sepsis.
• Patients who received anidulafungin for infection prophylaxis

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

London, SE5 9RS, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Candidiasis; Torulopsis; Candidemia; Systemic candidiasis

Interventions

Anidulafungin

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Candidiasis, Invasive; Invasive Fungal Infections; Fungemia; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Protocol-specified endpoint, percentage of participants with presumed eradication of infecting species, was not presented as a separate outcome measure because the 'presumed eradication' was considered same as favorable clinical response.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 15, 2010
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 16, 2014
• Results First Posted: October 11, 2012

Record last verified: 2014-03

Locations

GB (1)