ECMM Candida Registry - CandiReg

Invasive Candidiases Clinical Trial

— CandiReg  

Official title:

ECMM Candida Registry - CandiReg

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03450005
• Other study ID #: Candi001
• Status: Recruiting
• Start date: January 18, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: December 2023
• Source: University of Cologne
• Contact: Oliver Cornely, MD
• Phone: +49 221 478
• Email: oliver.cornely[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of the European Confederation of Medical Mycology - ECMM Candida Registry (CandiReg) is to overcome the lack of knowledge on epidemiology, clinical course, and molecular characteristics of invasive infections due to invasive Candida infections and to function as a platform for future studies and in case of outbreaks.

Description:

The specific objectives are:

To describe the global incidence of invasive Candida infection To monitor trends globally and locally over time To define patient risk groups To assess antifungal resistance among Candida spp. causing invasive diseases worldwide To assess attributable mortality of invasive Candida infection To assess incremental costs associated with invasive Candida infection

To describe the clinical pattern of disease To document diagnostic procedures performed for confirmation of diagnosis To describe first-line and salvage treatment regimens applied, guideline adherence, their efficacy and impact on patient survival To inform consensus guidelines To develop clinical screening and diagnostic procedures

Set up of a collection of isolates with molecular characterization and evaluation of resistance genes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cultural, histopathological, antigen or DNA evidence of invasive fungal infection with Candida species.

• Hepatosplenic candidiasis with signs of disseminated Candida infection without culture, histological or microscopic evidence

• Case control

Matching procedure for controls:

In part, controls will be included at the same hospitals that include cases (i.e. each one control per case, both in the same hospital).

Controls will be matched by demographics, underlying diseases and risk factors as well as duration of hospitalization

Exclusion Criteria:

• Colonization or other non-invasive infection, including superficial skin infections, candiduria without dissemination or Candida spp. in stool.

Related Conditions & MeSH terms

• Candidiasis
• Candidiasis, Invasive
• Invasive Candidiases

Locations

Country	Name	City	State
Germany	University Hospital Cologne	Cologne	NRW

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence	To describe the global incidence of invasive Candida infection	up to 100 weeks
Primary	Mortality	To describe the global mortality of invasive Candida infection	up to 100 weeks
Primary	Molecular characteristics of Candida auris	To describe the molecular characteristics of Candida auris	At 90 Days from diagnosis
Primary	Susceptibility testing	To describe the susceptibility of Candida auris	At 90 Days from diagnosis
Primary	Resistance development	To describe the resistance development of Candida auris	up to 100 weeks
Secondary	Treatment efficacy of invasive candida infections	Number of participants with treatment failure	At 90 Days from diagnosis
Secondary	Treatment efficacy of invasive candida infections	Number of participants with stable disease	At 90 Days from diagnosis
Secondary	Treatment efficacy of invasive candida infections	Number of participants with partial response	At 90 Days from diagnosis
Secondary	Treatment efficacy of invasive candida infections	Number of participants with complete response	At 90 Days from diagnosis