CandidemiaNCT02088476
Candidemia in a Pediatric Center and Importance of Central Venous Catheter Removal
An observational study of Candidemia, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Candidemia
- How many people
- 248 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2004to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children diagnosed with candidemia were included in our hospital between Jan 2004 and Dec 2012.
Who may be able to join
- Presence of growth of any candida species in at least one blood culture
Who cannot join
- Febrile neutropenic patients who were using empirical antifungal agents
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hacettepe University Faculty of Medicine
Ankara, 06100
About this study
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.
- Conditions
- Candidemia
- Keywords
- candidemia, children, mortality, risk factors
- Medical subject headings
- Candidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 months
Secondary outcomes (1)
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).
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startJan 2004
- Primary completionDec 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Karadag Oncel, MD, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088476
- Sponsor's protocol ID
- HUTF06
- Status last verified
- Mar 2014
- First submitted
- 10 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25678411
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Candidemia in a Pediatric Center and Importance of Central Venous Catheter Removal
- ClinicalTrials.gov ID
- NCT02088476
- Acronym / sponsor ID
- HUTF06
- Conditions
- Candidemia
- Keywords
- candidemia, children, mortality, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children diagnosed with candidemia were included in our hospital between Jan 2004 and Dec 2012.
Key inclusion criteria (1 listed)
- Presence of growth of any candida species in at least one blood culture
Key exclusion criteria (1 listed)
- Febrile neutropenic patients who were using empirical antifungal agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Prognosis according to candida species
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Derived from this study: PubMed 25678411Karadag-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Candidemia, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk factors of candidemia (time frame: up to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02088476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.