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Candidemia in a Pediatric Center and Importance of Central Venous Catheter Removal

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ClinicalTrials.gov Identifier: NCT02088476
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Eda Karadag Oncel, MD, Hacettepe University

Study Description
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Brief Summary:
Candidemia has emerged as an important cause of hospital-associated blood-stream infection in children. The purpose of this study was to identify differences in distribution of candida species, risk factors, treatment, and clinical outcome of candidemia in children. This study in children ≤18 years with blood culture proven candidemia identified between 2004 and 2012. Analyses included the determination of causative candida species, resistance to antifungals and clinical outcome, as well as the identification of potential risk factors associated with candidemia.

Condition or disease
Candidemia

Study Design
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Study Type : Observational
Actual Enrollment : 248 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : January 2004
Actual Primary Completion Date : December 2012
Actual Study Completion Date : June 2013
Groups and Cohorts
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Group/Cohort
Candidemia
Candidemia is defined as the presence of growth of any candida species in at least one blood culture obtained by either peripheral venipuncture or through an indwelling central venous catheter.


Outcome Measures
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Primary Outcome Measures :
  1. Risk factors of candidemia [ Time Frame: up to 3 months ]
    The presence or absence of potential risk factors for candidemia such as an indwelling central venous catheter (CVC), use of antibiotics (administered for >72 hours), use of antifungals (administered for >24 hours), immunosuppressants, total parenteral nutrition (TPN), admission to the intensive care unit (ICU), mechanical ventilation, neutropenia, hypoalbuminemia and hypophosphatemia.


Secondary Outcome Measures :
  1. Prognosis according to candida species [ Time Frame: up to 3 months ]
    Death which ensues within 30 days of the onset of candidemia with no apparent alternative cause is recognized as a candidemia-attributable mortality. Patients who died and survived were compared according to candida species (C.albicans, C. parapsilosis, C. tropicalis, C. sake, C.glabrata).


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children diagnosed with candidemia were included in our hospital between Jan 2004 and Dec 2012.
Criteria

Inclusion Criteria:

  • Presence of growth of any candida species in at least one blood culture

Exclusion Criteria:

  • Febrile neutropenic patients who were using empirical antifungal agents
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02088476


Locations
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Turkey
Hacettepe University Faculty of Medicine
Ankara, Turkey, 06100
Sponsors and Collaborators
Hacettepe University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eda Karadag Oncel, MD, Hacettepe University Department of Pediatric Infectious Diseases, Hacettepe University
ClinicalTrials.gov Identifier: NCT02088476    
Other Study ID Numbers: HUTF06
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Keywords provided by Eda Karadag Oncel, MD, Hacettepe University:
candidemia
children
mortality
risk factors
Additional relevant MeSH terms:
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Candidemia
Fungemia
Sepsis
Infection
Candidiasis, Invasive
Candidiasis
 Mycoses
Invasive Fungal Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes