NCT02088476

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 17, 2014

Completed
Last Updated

March 17, 2014

Status Verified

March 1, 2014

Enrollment Period

8.9 years

First QC Date

March 10, 2014

Last Update Submit

March 14, 2014

Conditions

Keywords

candidemiachildrenmortalityrisk factors

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Prognosis according to candida species

    up to 3 months

Study Arms (1)

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.

Eligibility Criteria

Age1 Day - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Children diagnosed with candidemia were included in our hospital between Jan 2004 and Dec 2012.

You may qualify if:

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

You may not qualify if:

  • Febrile neutropenic patients who were using empirical antifungal agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University Faculty of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (1)

  • Karadag-Oncel E, Kara A, Ozsurekci Y, Arikan-Akdagli S, Cengiz AB, Ceyhan M, Gur D, Celik M, Ozkaya-Parlakay A. Candidaemia in a paediatric centre and importance of central venous catheter removal. Mycoses. 2015 Mar;58(3):140-8. doi: 10.1111/myc.12288. Epub 2015 Feb 10.

MeSH Terms

Conditions

Candidemia

Condition Hierarchy (Ancestors)

Candidiasis, InvasiveCandidiasisMycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsFungemiaSepsisSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Hacettepe University Department of Pediatric Infectious Diseases

Study Record Dates

First Submitted

March 10, 2014

First Posted

March 17, 2014

Study Start

January 1, 2004

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

March 17, 2014

Record last verified: 2014-03

Locations