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
  Purpose

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
Candidemia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Early- and Late-onset Candidemia: A Retrospective Study

Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2011
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Candidemia patients
Patients with diagnosis of candidemia

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406093

Contacts
Contact: Francesco G. De Rosa, MD +390114393998 francescogiuseppe.derosa@unito.it

Locations
Italy
Hospital San Giovanni Battista - Molinette Recruiting
Torino, Italy, 10100
Contact: Francesco G De Rosa, MD    +390114393998    francescogiuseppe.derosa@unito.it   
Sub-Investigator: Roberto Serra, MD         
Sub-Investigator: Francesco G De Rosa, MD         
Principal Investigator: Giovanni Di Perri, MD, PhD         
Sponsors and Collaborators
University of Turin, Italy
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Giovanni Di Perri, MD, PhD University of Turin
Study Chair: Francesco G De Rosa, MD University of Turin
  More Information

No publications provided

Responsible Party: Prof. Giovanni Di Perri, University of Turin
ClinicalTrials.gov Identifier: NCT01406093     History of Changes
Other Study ID Numbers: EOC1-11
Study First Received: July 28, 2011
Last Updated: August 12, 2011
Health Authority: Italy: AIFA, Agenzia Italiana del FArmaco

Keywords provided by University of Turin, Italy:
Candidemia
Early-onset
Late-onset
Health-care associated
Nosocomial

Additional relevant MeSH terms:
Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
Mycoses
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014