Blood Stream InfectionsNCT01077336
Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
An observational study of Blood Stream Infections and Candida, run by University of Houston.
Trial summary
Susceptibility testing is commonly employed in patients with bacterial infections in order to guide rational use of antibiotics; however, the use of antifungal susceptibility testing is limited due to lack of availability, costs, and delays in receiving results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Stream Infections, Candida
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jan 2011
- 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: This will be a retrospective cohort study of 400 hospitalized patients with bloodstream infections from January 2006 to January 2009 due to Candida species
Who may be able to join
- Hospitalized patients with bloodstream infections due to Candida species
Who cannot join
- Patients will be excluded from this study if their medical charts contain incomplete outcome or susceptibility data. Patients treated empirically or definitively with amphotericin-based products will also be excluded
About this study
Susceptibility testing is commonly employed in patients with bacterial infections in order to guide rational use of antibiotics; however, the use of antifungal susceptibility testing is limited due to lack of availability, costs, and delays in receiving results. The goals of antifungal susceptibility testing should mirror those of antibacterial susceptibility testing: to predict clinical response or failure. Additionally, susceptibility reports should be used as a guide for physicians when transitioning patients from parenteral to oral antifungal agents. Currently, it is unknown whether antifungal susceptibility testing impacts treatment decisions in hospitals that routinely perform Candida susceptibility testing. The purpose of this study is to evaluate the changes in antifungal treatment based on in vitro susceptibility reports and how these decisions affect mortality, recurrence of infection, and length of hospital stay in candidemia patients.
- Conditions
- Blood Stream Infections, Candida
- Keywords
- susceptibility testing
- Medical subject headings
- Torulopsis
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 |
|---|---|---|
| Hospitalized patients with candidemia | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess empiric choice of antifungal therapy in hospitalized patients with candidemia.
Measured: Assessments made for 30-days after postivie blood culture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Stream InfectionsStudies 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
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Kevin W. Garey, University of Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077336
- Sponsor's protocol ID
- G098881
- Status last verified
- Jul 2014
- First submitted
- 25 Feb 2010
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes in Candidemia Patients Based on in Vitro Susceptibility
- ClinicalTrials.gov ID
- NCT01077336
- Acronym / sponsor ID
- G098881
- Conditions
- Blood Stream Infections, Candida
- Keywords
- susceptibility testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 1 Mar 2010 (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.
Susceptibility testing is commonly employed in patients with bacterial infections in order to guide rational use of antibiotics; however, the use of antifungal susceptibility testing is limited due to lack of availability, costs, and delays in receiving results. The goals of antifungal susceptibility testing should mirror those of antibacterial susceptibility testing: to predict clinical response or failure. Additionally, susceptibility reports should be used as a guide for physicians when transitioning patients from parenteral to oral antifungal agents. Currently, it is unknown whether antifungal susceptibility testing impacts treatment decisions in hospitals that routinely perform Candida susceptibility testing. The purpose of this study is to evaluate the changes in antifungal treatment based on in vitro susceptibility reports and how these decisions affect mortality, recurrence of infection, and length of hospital stay in candidemia patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized patients with candidemia | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a retrospective cohort study of 400 hospitalized patients with bloodstream infections from January 2006 to January 2009 due to Candida species
Key inclusion criteria (1 listed)
- Hospitalized patients with bloodstream infections due to Candida species
Key exclusion criteria (1 listed)
- Patients will be excluded from this study if their medical charts contain incomplete outcome or susceptibility data. Patients treated empirically or definitively with amphotericin-based products will also be excluded
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
Assess empiric choice of antifungal therapy in hospitalized patients with candidemia.
Time frame: Assessments made for 30-days after postivie blood culture
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 16 Jul 2014.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Stream Infections and Candida, run by University of Houston.
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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Assess empiric choice of antifungal therapy in hospitalized patients with candidemia. (time frame: Assessments made for 30-days after postivie blood culture). 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 16 Jul 2014.