ECMM Candida Registry - CandiReg

NCT ID: NCT03450005

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-18

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Invasive Candidiases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

emerging Candida isolates

Web-based registry of invasive infections by Candida species

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Cologne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oliver Cornely, MD

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Oliver Cornely, MD

Role: STUDY_CHAIR

University of Cologne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Cologne

Cologne, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Oliver Cornely, MD

Role: CONTACT

Phone: +49 221 478

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Oliver Cornely, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Candi001

Identifier Type: -

Identifier Source: org_study_id