Early- and Late-onset Candidemia

Candidemia Clinical Trial

Official title:

Early- and Late-onset Candidemia: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01406093
• Other study ID #: EOC1-11
• Status: Completed
• Phase: N/A
• First received: July 28, 2011
• Last updated: December 2, 2014
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2014
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA, Agenzia Italiana del FArmaco
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Candidemia

Locations

Country	Name	City	State
Italy	Hospital San Giovanni Battista - Molinette	Torino

Sponsors (2)

Lead Sponsor	Collaborator
Giovanni Di Perri	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days	No