ECMM Candida Registry - CandiReg (CandiReg)

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.

Study Overview

• Status: Recruiting
• Conditions: Invasive Candidiases

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 Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Oliver Cornely, MD; Phone Number: 85223 +49 221 478; Email: oliver.cornely@uk-koeln.de

Study Locations

• Germany
  • NRW
    • Cologne, NRW, Germany, 50937
      • Recruiting
      • University Hospital Cologne
      • Contact: Oliver Cornely, MD; Phone Number: 85523 +49 221 478; Email: oliver.cornely@uk-koeln.de
      • Sub-Investigator: Philipp Koehler, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Invasive infections caused by Candida species

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
emerging Candida isolates; Web-based registry of invasive infections by Candida species

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment efficacy of invasive candida infections	Number of participants with treatment failure	At 90 Days from diagnosis
Treatment efficacy of invasive candida infections	Number of participants with stable disease	At 90 Days from diagnosis
Treatment efficacy of invasive candida infections	Number of participants with partial response	At 90 Days from diagnosis
Treatment efficacy of invasive candida infections	Number of participants with complete response	At 90 Days from diagnosis

Collaborators and Investigators

• Sponsor: University of Cologne
• Investigators: Study Chair: Oliver Cornely, MD, University of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2018
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 2, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections and Mycoses; Mycoses; Invasive Fungal Infections; Candidiasis; Candidiasis, Invasive
• Other Study ID Numbers: Candi001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No