- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02088476
Candidemia in a Pediatric Center and Importance of Central Venous Catheter Removal
March 14, 2014 updated by: Eda Karadag Oncel, MD, Hacettepe University
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
248
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey, 06100
- Hacettepe University Faculty of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children diagnosed with candidemia were included in our hospital between Jan 2004 and Dec 2012.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
up to 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
March 10, 2014
First Submitted That Met QC Criteria
March 14, 2014
First Posted (Estimate)
March 17, 2014
Study Record Updates
Last Update Posted (Estimate)
March 17, 2014
Last Update Submitted That Met QC Criteria
March 14, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUTF06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.