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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01406093
Other study ID # EOC1-11
Secondary ID
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


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
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