ECMM Candida Registry - CandiReg

Study Overview
=================
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

Official Title
-----------------
ECMM Candida Registry - CandiReg

Conditions
-----------------
Invasive Candidiases

Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| emerging Candida isolates<br>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 |