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

Candidemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088476
• Other study ID #: HUTF06
• Status: Completed
• Phase: N/A
• First received: March 10, 2014
• Last updated: March 14, 2014
• Start date: January 2004
• Est. completion date: June 2013

Study information

• Verified date: March 2014
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Candidemia

Locations

Country	Name	City	State
Turkey	Hacettepe University Faculty of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors of candidemia	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.	up to 3 months	No
Secondary	Prognosis according to candida species	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).	up to 3 months	No