Invasive CandidiasesCandiRegNCT03450005
ECMM Candida Registry - CandiReg
An observational study of Invasive Candidiases, run by University of Cologne at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Invasive Candidiases
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jan 2018to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Invasive infections caused by Candida species
Who may be able to join
- 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
Who cannot join
- Colonization or other non-invasive infection, including superficial skin infections, candiduria without dissemination or Candida spp. in stool.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Cologne
Cologne, North Rhine-Westphalia, 50937
Oliver Cornely, MD, +49 221 478 ext. 85523, oliver.cornely@uk-koeln.de
Philipp Koehler, MD
About this study
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
- Conditions
- Invasive Candidiases
- Medical subject headings
- Candidiasis, Invasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| emerging Candida isolates | Web-based registry of invasive infections by Candida species |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
To describe the global incidence of invasive Candida infection
Measured: up to 100 weeks
Mortality
To describe the global mortality of invasive Candida infection
Measured: up to 100 weeks
Molecular characteristics of Candida auris
To describe the molecular characteristics of Candida auris
Measured: At 90 Days from diagnosis
Susceptibility testing
To describe the susceptibility of Candida auris
Measured: At 90 Days from diagnosis
Resistance development
To describe the resistance development of Candida auris
Measured: up to 100 weeks
Secondary outcomes (4)
Treatment efficacy of invasive candida infections
Number of participants with treatment failure
Measured: At 90 Days from diagnosis
Treatment efficacy of invasive candida infections
Number of participants with stable disease
Measured: At 90 Days from diagnosis
Treatment efficacy of invasive candida infections
Number of participants with partial response
Measured: At 90 Days from diagnosis
Treatment efficacy of invasive candida infections
Number of participants with complete response
Measured: At 90 Days from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start18 Jan 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive CandidiasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Cornely, MD, University of Cologne
- Investigators
- Oliver Cornely, MD, Study chair, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450005
- Sponsor's protocol ID
- Candi001
- Acronym
- CandiReg
- Status last verified
- Dec 2023
- First submitted
- 2 Feb 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECMM Candida Registry - CandiReg
- ClinicalTrials.gov ID
- NCT03450005
- Acronym / sponsor ID
- CandiReg / Candi001
- Conditions
- Invasive Candidiases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| emerging Candida isolates | – | –Web-based registry of invasive infections by Candida species |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Invasive infections caused by Candida species
Key inclusion criteria (6 listed)
- 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
- 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
Key exclusion criteria (1 listed)
- Colonization or other non-invasive infection, including superficial skin infections, candiduria without dissemination or Candida spp. in stool.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence
Time frame: up to 100 weeks
To describe the global incidence of invasive Candida infection
Mortality
Time frame: up to 100 weeks
To describe the global mortality of invasive Candida infection
Molecular characteristics of Candida auris
Time frame: At 90 Days from diagnosis
To describe the molecular characteristics of Candida auris
Susceptibility testing
Time frame: At 90 Days from diagnosis
To describe the susceptibility of Candida auris
Resistance development
Time frame: up to 100 weeks
To describe the resistance development of Candida auris
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Oliver Cornely, MD study chair
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Candidiases, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oliver Cornely, MD (+49 221 478 ext. 85223, oliver.cornely@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (time frame: up to 100 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.