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Early- and Late-onset Candidemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University of Turin, Italy.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01406093
First received: July 28, 2011
Last updated: August 12, 2011
Last verified: January 2011

July 28, 2011
August 12, 2011
May 2011
December 2011   (final data collection date for primary outcome measure)
Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01406093 on ClinicalTrials.gov Archive Site
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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.

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Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

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).

Candidemia
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Candidemia patients
Patients with diagnosis of candidemia
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Francesco G. De Rosa, MD +390114393998 francescogiuseppe.derosa@unito.it
Italy
 
NCT01406093
EOC1-11
No
Prof. Giovanni Di Perri, University of Turin
University of Turin, Italy
Merck Sharp & Dohme Corp.
Principal Investigator: Giovanni Di Perri, MD, PhD University of Turin
Study Chair: Francesco G De Rosa, MD University of Turin
University of Turin, Italy
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP