Early- and Late-onset Candidemia

Early- and Late-onset Candidemia: A Retrospective Study

A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. In the last years a growing body of knowledge has better characterized health-care associated (HCA) infections, which have been described in 2002 in outpatients with MRSA bloodstream infections. So far there is no compelling evidence that patients with HCA infections may develop candidemia before the usual timing of around 20-25 days after admission. Risk factors associated with HCA infections are represented by admission from long term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad spectrum antibiotics. There are few data HCA features and early onset candidemias in the published literature.

In this proposal, the investigators aim at studying early-onset candidemia in a retrospective study in one of the largest referral hospital in Italy with a consistent range of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU, complex surgery). The investigators speculate that patients with candidemia diagnosed within 10 days (early-onset) by the admission have different risk factors and prognosis of those with a late diagnosis.

Study Overview

• Status: Completed
• Conditions: Candidemia

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10100
    • Hospital San Giovanni Battista - Molinette

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The selection of patients for inclusion will be based on microbiological data (with suscesptibilty patterns of the various antifungals) extracted from the computerized archive with search for Candida spp. and "blood" either peripheral or from a central venous catheter. Candida isolated from a removed CVC tip will not be considered. The candidemia will also be defined early or late based on the time elapsed between hospital admission and diagnosis (≤ 10 days early, > 10 days late candidemia).

Description

Inclusion Criteria:

• Candidemia diagnosed with positive blood culture either from a peripheral vein or CVC

Exclusion Criteria:

• Candida isolated from a removed CVC tip will not be considered

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Candidemia patients; Patients with diagnosis of candidemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 days

Collaborators and Investigators

• Sponsor: Giovanni Di Perri
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Giovanni Di Perri, MD, PhD, University of Turin, Italy; Study Chair: Francesco G De Rosa, MD, University of Turin, Italy

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: July 28, 2011
• First Posted (Estimate): July 29, 2011

Study Record Updates

• Last Update Posted (Estimate): December 4, 2014
• Last Update Submitted That Met QC Criteria: December 2, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Candidemia; Early-onset; Late-onset; Health-care associated; Nosocomial
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections and Mycoses; Sepsis; Mycoses; Invasive Fungal Infections; Fungemia; Candidiasis; Candidiasis, Invasive; Candidemia
• Other Study ID Numbers: EOC1-11