ECMM Candida Registry - CandiReg

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03450005

Acronym

CandiReg

Enrollment

2000

Registered

2018-03-01

Start date

2018-01-18

Completion date

2026-12-31

Last updated

2023-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Invasive Candidiases

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Resistance development	up to 100 weeks	To describe the resistance development of Candida auris
Incidence	up to 100 weeks	To describe the global incidence of invasive Candida infection
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
Susceptibility testing	At 90 Days from diagnosis	To describe the susceptibility of Candida auris

Secondary

Measure	Time frame	Description
Treatment efficacy of invasive candida infections	At 90 Days from diagnosis	Number of participants with treatment failure

Countries

Germany

Contacts

Primary ContactOliver Cornely, MD

oliver.cornely@uk-koeln.de+49 221 478

Outcome results