ECMM Candida Registry - CandiReg

NCT03450005 | Recruiting

• 1 other identifier: Candi001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Invasive Candidiases

Outcome Measures

Primary Outcomes (5)

• Incidence

  To describe the global incidence of invasive Candida infection

  up to 100 weeks

• Mortality

  To describe the global mortality of invasive Candida infection

  up to 100 weeks

• Molecular characteristics of Candida auris

  To describe the molecular characteristics of Candida auris

  At 90 Days from diagnosis

• Susceptibility testing

  To describe the susceptibility of Candida auris

  At 90 Days from diagnosis

• Resistance development

  To describe the resistance development of Candida auris

  up to 100 weeks

Secondary Outcomes (4)

• Treatment efficacy of invasive candida infections

  At 90 Days from diagnosis

• Treatment efficacy of invasive candida infections

  At 90 Days from diagnosis

• Treatment efficacy of invasive candida infections

  At 90 Days from diagnosis

• Treatment efficacy of invasive candida infections

  At 90 Days from diagnosis

Study Arms (1)

emerging Candida isolates

Web-based registry of invasive infections by Candida species

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invasive infections caused by Candida species

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University Hospital Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

fungal culture

MeSH Terms

Conditions

Candidiasis, Invasive

Condition Hierarchy (Ancestors)

Candidiasis; Mycoses; Bacterial Infections and Mycoses; Infections; Invasive Fungal Infections

Study Officials

• Oliver Cornely, MD

  University of Cologne

  STUDY CHAIR

Central Study Contacts

Oliver Cornely, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: February 2, 2018
• First Posted: March 1, 2018
• Study Start: January 18, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

DE (1)