FungemiaCANDIPOPNCT01236261
Prospective Population Study on Candidemia in Spain
An observational study of Fungemia, run by Fundacion SEIMC-GESIDA at 29 sites in Spain.
Trial summary
The aim of this study is to describe the epidemiology of fungal blood infections in Spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fungemia
- What is being tested?
- Non intervention
- How many people
- 730 participants
- Where
- 29 sitesSpain
- Study dates
- Mar 2013to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)
Who may be able to join
- Fungal isolate obtained from blood sample
Who cannot join
- None
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
Spain29 sites
Hospital Fundación de Alcorcón
Alcorcón, Madrid, 28922
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital de Barcelona
Barcelona, Barcelona, 08034
Hospital Vall d'Hebrón
Barcelona, Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, Barcelona, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08041
Hospital de Basurto
Basurto, Vizcaya, 48013
Hospital San Juan de Dios del Aljarafe
Bormujos, Seville, 41930
Hospital Sant Joan de Dèu
Esplugues de Llobregat, Barcelona, 08950
Hospital de Galdakao-Usansolo
Galdakao, Vizcaya, 48960
Hospital de la Princesa
Madrid, Madrid, 28006
Hospital Gregorio Marañon
Madrid, Madrid, 28007
Hospital del Niño Jesús
Madrid, Madrid, 28009
Hospital Infanta Leonor
Madrid, Madrid, 28032
Hospital Ramon y Cajal
Madrid, Madrid, 28034
Fundación Jiménez Díaz
Madrid, Madrid, 28040
Hospital Clínico San Carlos
Madrid, Madrid, 28040
Hospital 12 de Octubre
Madrid, Madrid, 28041
Hospital La Paz
Madrid, Madrid, 28046
Hospital Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Virgen de Macarena
Seville, Seville, 41009
Clínica Sagrado Corazón
Seville, Seville, 41013
Hospital Virgen del Rocío
Seville, Seville, 41013
Hospital Nuestra Señora de Valme
Seville, Seville, 41014
Hospital La Fe
Valencia, Valencia, 46009
Hospital Clínico de Valencia
Valencia, Valencia, 46010
Hospital General de Valencia
Valencia, Valencia, 46014
Hospital Doctor Peset
Valencia, Valencia, 46017
About this study
Official title: Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)
The aim of this study is to describe the epidemiology of fungal blood infections in Spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). The study is to be performed in five big cities which represent different geographic areas: Barcelona, Bilbao, Madrid, Sevilla and Valencia.
- Conditions
- Fungemia
- Being tested
- Non intervention
- Keywords
- Fungemia, fungal infection, susceptibility, antifungal
- Medical subject headings
- Fungemia, Mycoses, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventionOther
Non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Fungemia | Patients with a fungal isolate from a blood culture Receives: Other: Non intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe fungemia epidemiology in Spain
Recollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.
Measured: 1 year
Secondary outcomes (5)
Describe differences among cities and institutions
Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)
Measured: 1 year
Definition of risk factors
Determine risk factors for:
- bad clinical evolution
- infection by a specific Candida species
- fluconazole resistant isolate
- fungemia persistency
Measured: 1 year
Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B
Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal
Measured: 1 year
Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution
Chi-square and Kaplan-Meier survival curves
Measured: 1 year
Correlation between reference and commercial microbiological methods
Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startMar 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FungemiaStudies 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
- 730 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer
- Responsible party
- Sponsor
- Investigators
- Manuel Cuenca, MD, PhD, Study director, Instituto de Salud Carlos IIIBelen Padilla, MD, Study director, Hospital Gregorio MarañonIsabel Ruiz, MD, Study director, Hospital Vall d'HebronJose Garnacho-Montero, MD, Study director, Hospital Virgen del Rocio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01236261
- Sponsor's protocol ID
- GEMICOMED-GEIH 0109
- Acronym
- CANDIPOP
- Status last verified
- Apr 2013
- First submitted
- 5 Nov 2010
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puig-Asensio M, Fernandez-Ruiz M, Aguado JM, Merino P, Lora-Pablos D, Guinea J, Martin-Davila P, Cuenca-Estrella M, Almirante B. Propensity Score Analysis of the Role of Initial Antifungal Therapy in the Outcome of Candida glabrata Bloodstream Infections. Antimicrob Agents Chemother. 2016 May 23;60(6):3291-300. doi: 10.1128/AAC.00195-16. Print 2016 Jun.
PubMed 26976872
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Population Study on Candidemia in Spain (Estudio Poblacional Prospectivo Sobre Candidemia en España)
- ClinicalTrials.gov ID
- NCT01236261
- Acronym / sponsor ID
- CANDIPOP / GEMICOMED-GEIH 0109
- Conditions
- Fungemia
- Keywords
- Fungemia, fungal infection, susceptibility, antifungal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 730 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Gilead Sciences, Merck Sharp & Dohme LLC, Pfizer
- Study start
- Mar 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 8 Nov 2010 (estimated)
- 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 aim of this study is to describe the epidemiology of fungal blood infections in Spain (with emphasis on the incidence, fungal species distribution and antifungal susceptibility). The study is to be performed in five big cities which represent different geographic areas: Barcelona, Bilbao, Madrid, Sevilla and Valencia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fungemia | – | Other: Non interventionPatients with a fungal isolate from a blood culture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with Candida sp or other fungal isolate obtained from a blood sample (fungemia episode)
Key inclusion criteria (1 listed)
- Fungal isolate obtained from blood sample
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non interventionNon interventional study | Other | Fungemia |
Primary outcome
Describe fungemia epidemiology in Spain
Time frame: 1 year
Recollection of demographic variables (age, gender and ethnic origin); clinical variables (background diseases, other coinfections, treatment received, etc) and microbiological information of the isolate.
5 secondary outcomes
Describe differences among cities and institutions
Time frame: 1 year
Definition of risk factors
Time frame: 1 year
Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B
Time frame: 1 year
Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution
Time frame: 1 year
Correlation between reference and commercial microbiological methods
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
- Derived from this study: PubMed 26976872Puig-Asensio M, Fernandez-Ruiz M, Aguado JM, Merino P, Lora-Pablos D, Guinea J, Martin-Davila P, Cuenca-Estrella M, Almirante B. Propensity Score Analysis of the Role of Initial Antifungal Therapy in the Outcome of Candida glabrata Bloodstream Infections. Antimicrob Agents Chemother. 2016 May 23;60(6):3291-300. doi: 10.1128/AAC.00195-16. Print 2016 Jun.
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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. This study is not recruiting at the moment.
Manuel Cuenca, MD, PhD study director
Instituto de Salud Carlos III
Belen Padilla, MD study director
Hospital Gregorio Marañon
Isabel Ruiz, MD study director
Hospital Vall d'Hebron
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungemia, run by Fundacion SEIMC-GESIDA at 29 sites in Spain.
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 1 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: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe fungemia epidemiology in Spain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01236261, which also lists 1 linked publication.
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 23 Apr 2013.