Early- and Late-onset Candidemia

NCT01406093 | Completed

• 1 other identifier: EOC1-11
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Candidemia

Keywords

Candidemia; Early-onset; Late-onset; Health-care associated; Nosocomial

Outcome Measures

Primary Outcomes (1)

• Mortality

  30 days

Study Arms (1)

Candidemia patients

Patients with diagnosis of candidemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Giovanni Di Perri: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Hospital San Giovanni Battista - Molinette

Torino, 10100, Italy

Location

MeSH Terms

Conditions

Candidemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Giovanni Di Perri, MD, PhD

  University of Turin, Italy

  PRINCIPAL INVESTIGATOR

• Francesco G De Rosa, MD

  University of Turin, Italy

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Early- and Late-onset Candidemia

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: May 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 4, 2014

Record last verified: 2014-12

Locations

IT (1)