Candida FungemiaNCT03827330
Retrospective Chart Review of Candida Fungemia
An observational study of Candida Fungemia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: Candida can cause infections. The most common kind of Candida at clinics is C albicans. But other kinds have increased at clinics too. Researchers want to review the records of people who were in previous NIH studies who had Candida. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Candida Fungemia
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2019to 18 Nov 2020
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had Candida species grown from blood cultures drawn at the National Institutes of Health from 2004 until 2017.
- The study will involve only review of patient records and will not require new specimens or participant contact. The patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s).
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID)
Bethesda, Maryland, 20892
About this study
Background:
Candida can cause infections. The most common kind of Candida at clinics is C albicans. But other kinds have increased at clinics too. Researchers want to review the records of people who were in previous NIH studies who had Candida. They want to find out what risk factors are associaated with this infection.
Read more
Objective:
To study the factors that are associated with Candida fungemia to develop. The factors are clinical features, diagnoses, and previous antifungal therapy.
Eligibility:
People who were in prior NIH studies and had Candida
Design:
Researchers will review the records of 62 NIH participants. The records are from 2004 to 2017. They will look at data such as blood test results, diagnosis, and treatments.
Researchers will only reach out to participants if they get approval from a review board.
This research will probably not reveal data that would be important to participants health. But if it does, researchers will try to contact those participants.
Data will be stored in secure computers. They will be stored with a code that only the study team can link to a participant.
Read the detailed description
This protocol is a chart review of patients who had Candida species grown from blood cultures drawn at the National Institutes of Health. The study will involve only review of patient records and will not require new specimens or participant contact. The patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s). Principal investigators of each protocol have been contacted to request permission to conduct this study, and to verify that none of the original protocols or informed consent documents precludes such a review of clinical data.
- Conditions
- Candida Fungemia
- Keywords
- Candida Parapsilosis, Candida Auris, Candida Lusitaniae, Candida Glabrata, Candida Albicans
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 |
|---|---|---|
| Patients | Patients who had Candida species growth from blood cultures drawn at the National Institutes of Health |
What is being measured
The primary outcome is the main question the study is designed to answer.
The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of n...
The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of non-albicans species of Candida.
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start3 Jan 2019
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Candida FungemiaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- 75 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michail S Lionakis, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827330
- Sponsor's protocol ID
- 999919037
- Other IDs
- 19-I-N037
- Status last verified
- Nov 2020
- First submitted
- 31 Jan 2019
- Last updated
- 27 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Chart Review of Candida Fungemia
- ClinicalTrials.gov ID
- NCT03827330
- Acronym / sponsor ID
- 999919037
- Conditions
- Candida Fungemia
- Keywords
- Candida Parapsilosis, Candida Auris, Candida Lusitaniae, Candida Glabrata, Candida Albicans
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- 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.
Background:
Candida can cause infections. The most common kind of Candida at clinics is C albicans. But other kinds have increased at clinics too. Researchers want to review the records of people who were in previous NIH studies who had Candida. They want to find out what risk factors are associaated with this infection.
Objective:
To study the factors that are associated with Candida fungemia to develop. The factors are clinical features, diagnoses, and previous antifungal therapy.
Eligibility:
People who were in prior NIH studies and had Candida
Design:
Researchers will review the records of 62 NIH participants. The records are from 2004 to 2017. They will look at data such as blood test results, diagnosis, and treatments.
Researchers will only reach out to participants if they get approval from a review board.
This research will probably not reveal data that would be important to participants health. But if it does, researchers will try to contact those participants.
Data will be stored in secure computers. They will be stored with a code that only the study team can link to a participant.
Detailed description
This protocol is a chart review of patients who had Candida species grown from blood cultures drawn at the National Institutes of Health. The study will involve only review of patient records and will not require new specimens or participant contact. The patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s). Principal investigators of each protocol have been contacted to request permission to conduct this study, and to verify that none of the original protocols or informed consent documents precludes such a review of clinical data.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients who had Candida species growth from blood cultures drawn at the National Institutes of Health |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had Candida species grown from blood cultures drawn at the National Institutes of Health from 2004 until 2017.
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
The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of n...
Time frame: Duration of study
The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of non-albicans species of Candida.
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 27 Nov 2020.
Related trials for Candida Fungemia
RecruitingPhase 3
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Participants With Candidemia and/or Invasive Candidiasis.
Candidemia, Candidiasis, Invasive
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.
Michail S Lionakis, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Candida Fungemia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 27 Nov 2020. 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 United States. 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?
The objective of this protocol is to characterize the clinical features, underlying diagnoses, previous antimicrobial therapy, and previous antifungal therapy associated with the development of Candida fungemia, as well as the enrichment of n... (time frame: Duration of study). 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 27 Nov 2020.