Clinical trial NCT03450005: ECMM Candida Registry - CandiReg
Official title: ECMM Candida Registry - CandiReg
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Candidiases
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Invasive infections caused by Candida species

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

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.

Primary outcomes:
measure: Incidence
timeFrame: up to 100 weeks
measure: Mortality
timeFrame: up to 100 weeks
measure: Molecular characteristics of Candida auris
timeFrame: At 90 Days from diagnosis
measure: Susceptibility testing
timeFrame: At 90 Days from diagnosis
measure: Resistance development
timeFrame: up to 100 weeks
Secondary outcomes:
measure: Treatment efficacy of invasive candida infections
timeFrame: At 90 Days from diagnosis
measure: Treatment efficacy of invasive candida infections
timeFrame: At 90 Days from diagnosis
measure: Treatment efficacy of invasive candida infections
timeFrame: At 90 Days from diagnosis
measure: Treatment efficacy of invasive candida infections
timeFrame: At 90 Days from diagnosis
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
Study officials:
affiliation: University of Cologne
name: Oliver Cornely, MD
role: STUDY_CHAIR
References: