Retrospective Chart Review of Candida Fungemia

Candida Fungemia Clinical Trial

Official title:

Retrospective Chart Review of Candida Fungemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03827330
• Other study ID #: 999919037
• Secondary ID: 19-I-N037
• Status: Completed
• Start date: January 3, 2019
• Est. completion date: November 18, 2020

Study information

• Verified date: November 2020
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

• 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).

Related Conditions & MeSH terms

• Candida Fungemia
• Fungemia

Locations

Country	Name	City	State
United States	National Institute of Allergy and Infectious Diseases (NIAID)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration of study