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NCT Number: NCT03450005

ECMM Candida Registry - CandiReg

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location status: Recruiting

Location contact

Oliver Cornely, MD

CONTACT

[email protected]

+49 221 478 ext. 85523

Philipp Koehler, MD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Incidence

    Time frame: up to 100 weeks

    To describe the global incidence of invasive Candida infection

  2. Mortality

    Time frame: up to 100 weeks

    To describe the global mortality of invasive Candida infection

  3. Molecular characteristics of Candida auris

    Time frame: At 90 Days from diagnosis

    To describe the molecular characteristics of Candida auris

  4. Susceptibility testing

    Time frame: At 90 Days from diagnosis

    To describe the susceptibility of Candida auris

  5. Resistance development

    Time frame: up to 100 weeks

    To describe the resistance development of Candida auris

Secondary outcomes

  1. Treatment efficacy of invasive candida infections

    Time frame: At 90 Days from diagnosis

    Number of participants with treatment failure

  2. Treatment efficacy of invasive candida infections

    Time frame: At 90 Days from diagnosis

    Number of participants with stable disease

  3. Treatment efficacy of invasive candida infections

    Time frame: At 90 Days from diagnosis

    Number of participants with partial response

  4. Treatment efficacy of invasive candida infections

    Time frame: At 90 Days from diagnosis

    Number of participants with complete response

Study contacts

Contact information is provided by the study sponsor or research team.

Oliver Cornely, MD

CONTACT

[email protected]

+49 221 478 ext. 85223

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Acronym: CandiReg

Important dates

Study start
2018
Primary completion
2025
Study completion
2026
First posted
Mar 1, 2018
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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