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RecruitingNCT03450005CandiRegUpdated Dec 12, 2023

ECMM Candida Registry - CandiReg

An observational study in Invasive Candidiases, sponsored by University of Cologne. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2023-12-12.

Sponsored by University of Cologne · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Invasive Candidiases
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Invasive infections caused by Candida species

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

Exclusion Criteria:

  • Colonization or other non-invasive infection, including superficial skin infections, candiduria without dissemination or Candida spp. in stool.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • emerging Candida isolates

    Web-based registry of invasive infections by Candida species

05

What researchers measure

Primary outcomes

  1. Incidence

    To describe the global incidence of invasive Candida infection

    Time frame: up to 100 weeks

  2. Mortality

    To describe the global mortality of invasive Candida infection

    Time frame: up to 100 weeks

  3. Molecular characteristics of Candida auris

    To describe the molecular characteristics of Candida auris

    Time frame: At 90 Days from diagnosis

  4. Susceptibility testing

    To describe the susceptibility of Candida auris

    Time frame: At 90 Days from diagnosis

  5. Resistance development

    To describe the resistance development of Candida auris

    Time frame: up to 100 weeks

Secondary outcomes

  1. Treatment efficacy of invasive candida infections

    Number of participants with treatment failure

    Time frame: At 90 Days from diagnosis

  2. Treatment efficacy of invasive candida infections

    Number of participants with stable disease

    Time frame: At 90 Days from diagnosis

  3. Treatment efficacy of invasive candida infections

    Number of participants with partial response

    Time frame: At 90 Days from diagnosis

  4. Treatment efficacy of invasive candida infections

    Number of participants with complete response

    Time frame: At 90 Days from diagnosis

06

Study locations

1 of 1 sites recruiting
  • University Hospital Cologne
    Cologne, NRW 50937, Germany
    Recruiting
07

Registry details

Key details

Study ID
NCT03450005
Lead sponsor
University of Cologne
Responsible party
Oliver Cornely, MD (Prof. Dr. med., University of Cologne) — Principal investigator
First posted
Mar 1, 2018
Start date
Jan 18, 2018
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Dec 12, 2023

Study contacts

Oliver Cornely, MD
Contact
oliver.cornely@uk-koeln.de
+49 221 478 ext. 85223
Oliver Cornely, MD
study chair · University of Cologne

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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