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Early- and Late-onset Candidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406093
Recruitment Status : Completed
First Posted : July 29, 2011
Last Update Posted : December 4, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Giovanni Di Perri, University of Turin, Italy

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.

Condition or disease

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early- and Late-onset Candidemia: A Retrospective Study
Study Start Date : May 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : June 2012

Candidemia patients
Patients with diagnosis of candidemia

Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406093

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Hospital San Giovanni Battista - Molinette
Torino, Italy, 10100
Sponsors and Collaborators
Giovanni Di Perri
Merck Sharp & Dohme Corp.
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Principal Investigator: Giovanni Di Perri, MD, PhD University of Turin, Italy
Study Chair: Francesco G De Rosa, MD University of Turin, Italy
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Responsible Party: Giovanni Di Perri, Early- and Late-onset Candidemia, University of Turin, Italy Identifier: NCT01406093    
Other Study ID Numbers: EOC1-11
First Posted: July 29, 2011    Key Record Dates
Last Update Posted: December 4, 2014
Last Verified: December 2014
Keywords provided by Giovanni Di Perri, University of Turin, Italy:
Health-care associated
Additional relevant MeSH terms:
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Candidiasis, Invasive
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes