ECMM Candida Registry - CandiReg

Recruiting

• Conditions: Invasive Candidiases

• Registration Number: NCT03450005
• Lead Sponsor: University of Cologne

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2018-01-18
• Study First Submitted: 2018-02-02
• Study First Submitted QC: 2018-02-22
• Study First Posted: 2018-03-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	up to 100 weeks	To describe the global mortality of invasive Candida infection
Molecular characteristics of Candida auris	At 90 Days from diagnosis	To describe the molecular characteristics of Candida auris
Resistance development	up to 100 weeks	To describe the resistance development of Candida auris
Susceptibility testing	At 90 Days from diagnosis	To describe the susceptibility of Candida auris
Incidence	up to 100 weeks	To describe the global incidence of invasive Candida infection

Secondary Outcome Measures

Name	Time	Method
Treatment efficacy of invasive candida infections	At 90 Days from diagnosis	Number of participants with complete response

Trial Locations

Locations (1)

University Hospital Cologne; 🇩🇪 Cologne, NRW, Germany