ECMM Candida Registry - CandiReg
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Invasive Candidiases. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Primary outcome measures
- Incidence [Time frame: up to 100 weeks]
- Mortality [Time frame: up to 100 weeks]
- Molecular characteristics of Candida auris [Time frame: At 90 Days from diagnosis]
- Susceptibility testing [Time frame: At 90 Days from diagnosis]
- Resistance development [Time frame: up to 100 weeks]
Secondary outcome measures (4)
- Treatment efficacy of invasive candida infections [Time frame: At 90 Days from diagnosis]
- Treatment efficacy of invasive candida infections [Time frame: At 90 Days from diagnosis]
- Treatment efficacy of invasive candida infections [Time frame: At 90 Days from diagnosis]
- Treatment efficacy of invasive candida infections [Time frame: At 90 Days from diagnosis]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Germany · 1 center
- University Hospital Cologne — Cologne
Identifiers
NCT: NCT03450005 · Candi001