CandidemiaNCT01406093
Early- and Late-onset Candidemia
An observational study of Candidemia, run by Giovanni Di Perri at 1 site in Italy.
Trial summary
A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. In the last years a growing body of knowledge has better characterized health-care associated (HCA) infections, which have been described in 2002 in outpatients with MRSA bloodstream infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Candidemia
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- May 2011to Jun 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The selection of patients for inclusion will be based on microbiological data (with suscesptibilty patterns of the various antifungals) extracted from the computerized archive with search for Candida spp. and "blood" either peripheral or from a central venous catheter. Candida isolated from a removed CVC tip will not be considered. The candidemia will also be defined early or late based on the time elapsed between hospital admission and diagnosis (≤ 10 days early, > 10 days late candidemia).
Who may be able to join
- Candidemia diagnosed with positive blood culture either from a peripheral vein or CVC
Who cannot join
- Candida isolated from a removed CVC tip will not be considered
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early- and Late-onset Candidemia: A Retrospective Study
A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. In the last years a growing body of knowledge has better characterized health-care associated (HCA) infections, which have been described in 2002 in outpatients with MRSA bloodstream infections. So far there is no compelling evidence that patients with HCA infections may develop candidemia before the usual timing of around 20-25 days after admission. Risk factors associated with HCA infections are represented by admission from long term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad spectrum antibiotics. There are few data HCA features and early onset candidemias in the published literature.
In this proposal, the investigators aim at studying early-onset candidemia in a retrospective study in one of the largest referral hospital in Italy with a consistent range of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU, complex surgery). The investigators speculate that patients with candidemia diagnosed within 10 days (early-onset) by the admission have different risk factors and prognosis of those with a late diagnosis.
- Conditions
- Candidemia
- Keywords
- Candidemia, Early-onset, Late-onset, Health-care associated, Nosocomial
- 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 patients | Patients with diagnosis of candidemia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CandidemiaStudies of the same condition, open and under way.
- 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
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giovanni Di Perri
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor-investigator, Giovanni Di Perri, University of Turin, Italy
- Investigators
- Giovanni Di Perri, MD, PhD, Principal investigator, University of Turin, ItalyFrancesco G De Rosa, MD, Study chair, University of Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406093
- Sponsor's protocol ID
- EOC1-11
- Status last verified
- Dec 2014
- First submitted
- 28 Jul 2011
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early- and Late-onset Candidemia: A Retrospective Study
- ClinicalTrials.gov ID
- NCT01406093
- Acronym / sponsor ID
- EOC1-11
- Conditions
- Candidemia
- Keywords
- Candidemia, Early-onset, Late-onset, Health-care associated, Nosocomial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Giovanni Di PerriUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- May 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 29 Jul 2011 (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.
A timing diagnosis of candidemia is as important as the correct choice of empiric or targeted antifungal therapy. In the last years a growing body of knowledge has better characterized health-care associated (HCA) infections, which have been described in 2002 in outpatients with MRSA bloodstream infections. So far there is no compelling evidence that patients with HCA infections may develop candidemia before the usual timing of around 20-25 days after admission. Risk factors associated with HCA infections are represented by admission from long term chronic care facilities (LTCF), haemodialysis, previous admission or parenteral broad spectrum antibiotics. There are few data HCA features and early onset candidemias in the published literature.
In this proposal, the investigators aim at studying early-onset candidemia in a retrospective study in one of the largest referral hospital in Italy with a consistent range of specialties ranging (bone marrow transplant, solid organ transplant, immunosuppressed patients, ICU, complex surgery). The investigators speculate that patients with candidemia diagnosed within 10 days (early-onset) by the admission have different risk factors and prognosis of those with a late diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Candidemia patients | – | –Patients with diagnosis of candidemia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The selection of patients for inclusion will be based on microbiological data (with suscesptibilty patterns of the various antifungals) extracted from the computerized archive with search for Candida spp. and "blood" either peripheral or from a central venous catheter. Candida isolated from a removed CVC tip will not be considered. The candidemia will also be defined early or late based on the time elapsed between hospital admission and diagnosis (≤ 10 days early, > 10 days late candidemia).
Key inclusion criteria (1 listed)
- Candidemia diagnosed with positive blood culture either from a peripheral vein or CVC
Key exclusion criteria (1 listed)
- Candida isolated from a removed CVC tip will not be considered
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
Mortality
Time frame: 30 days
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 4 Dec 2014.
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A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
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Shortening Treatment Duration in Uncomplicated Candidemia: the CanTEN Trial
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Candidemia
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.
Giovanni Di Perri, MD, PhD principal investigator
University of Turin, Italy
Francesco G De Rosa, MD study chair
University of Turin, Italy
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 Giovanni Di Perri at 1 site in Italy.
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 4 Dec 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 Italy. 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?
Mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2014.