NCT05235711

Brief Summary

The purpose of the study is to investigate the role of the human immune response to candidemia/invasive candidiasis as it relates to the cytokine interferon-gamma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

October 9, 2024

Status Verified

October 1, 2024

Enrollment Period

2.6 years

First QC Date

January 4, 2022

Last Update Submit

October 7, 2024

Conditions

Fungal InfectionCandidiasis

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    All-cause mortality

    30 days

Secondary Outcomes (4)

  • Serum concentration of IFN-gamma and other cytokines by multiplex ELISA

    1 week

  • Plasma IFN-gamma concentration after dual innate and adaptive immune system stimulation by QuantiFERON Monitor assay

    1 week

  • Intracellular expression of IFN-gamma expression by a CD8 T-cell competence assay

    1 week

  • In vitro antifungal activity of polymorphonuclear leukocytes in the presence or absence of interferon-gamma by colorimetric method

    1 week

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with Candida bloodstream infection, peritonitis/intra-abdominal abscess, and pleural empyema

You may qualify if:

  • Willing and able to provide written informed consent. If the subject is unable to consent for himself/herself, a legally authorized representative must provide informed consent on his/her behalf.
  • Males or females ≥18 years of age
  • Patients having one or more systemic signs attributable to candidemia or invasive candidiasis (fever, hypothermia, hypotension, tachycardia, tachypnea, local signs of inflammation).
  • Isolation of Candida from blood, intra-abdominal abscess/peritoneal fluid or pleural fluid.

You may not qualify if:

  • Severe neutropenia (absolute neutrophil count \<500 cells/microL)
  • Profound lymphopenia (\<300 cells/microL)
  • The Principal Investigator (PI) is of the opinion the subject should not participate in the study.
  • Females who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum/plasma

MeSH Terms

Conditions

MycosesCandidiasis

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Paschalis Vergidis, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 4, 2022

First Posted

February 11, 2022

Study Start

February 10, 2022

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

October 9, 2024

Record last verified: 2024-10

Locations

US(1)