CANDIPOP: Prospective Population Study on Candidemia in Spain
Study Details
Study Description
Brief 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).
The study is to be performed in five big cities which represent different geographic areas:
Barcelona, Bilbao, Madrid, Sevilla and Valencia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fungemia Patients with a fungal isolate from a blood culture |
Other: Non intervention
Non interventional study
|
Outcome Measures
Primary Outcome Measures
- Describe fungemia epidemiology in Spain [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.
Secondary Outcome Measures
- Describe differences among cities and institutions [1 year]
Analyze results in function of the city and hospital where the isolate was obtained (5 cities in Spain and 29 participating hospitals)
- Definition of risk factors [1 year]
Determine risk factors for: bad clinical evolution infection by a specific Candida species fluconazole resistant isolate fungemia persistency
- Determination of the fungal isolates susceptibility to fluconazole, voriconazole, caspofungine, anidulafungine, micafungine and anfotericine B [1 year]
Analysis of resistant strains percentage according to the threshold established by CLSI to each specific antifungal
- Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution [1 year]
Chi-square and Kaplan-Meier survival curves
- Correlation between reference and commercial microbiological methods [1 year]
Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Fungal isolate obtained from blood sample
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Sant Joan de Dèu | Esplugues de Llobregat | Barcelona | Spain | 08950 |
| 2 | Hospital Fundación de Alcorcón | Alcorcón | Madrid | Spain | 28922 |
| 3 | Hospital Puerta de Hierro Majadahonda | Majadahonda | Madrid | Spain | 28222 |
| 4 | Hospital San Juan de Dios del Aljarafe | Bormujos | Seville | Spain | 41930 |
| 5 | Hospital de Cruces | Baracaldo | Vizcaya | Spain | 48903 |
| 6 | Hospital de Basurto | Basurto | Vizcaya | Spain | 48013 |
| 7 | Hospital de Galdakao-Usansolo | Galdakao | Vizcaya | Spain | 48960 |
| 8 | Hospital del Mar | Barcelona | Spain | 08003 | |
| 9 | Hospital de Barcelona | Barcelona | Spain | 08034 | |
| 10 | Hospital Vall d'Hebrón | Barcelona | Spain | 08035 | |
| 11 | Hospital Clinic i Provincial | Barcelona | Spain | 08036 | |
| 12 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | 08041 | |
| 13 | Hospital de la Princesa | Madrid | Spain | 28006 | |
| 14 | Hospital Gregorio Marañon | Madrid | Spain | 28007 | |
| 15 | Hospital del Niño Jesús | Madrid | Spain | 28009 | |
| 16 | Hospital Infanta Leonor | Madrid | Spain | 28032 | |
| 17 | Hospital Ramon y Cajal | Madrid | Spain | 28034 | |
| 18 | Fundación Jiménez Díaz | Madrid | Spain | 28040 | |
| 19 | Hospital Clínico San Carlos | Madrid | Spain | 28040 | |
| 20 | Hospital 12 de Octubre | Madrid | Spain | 28041 | |
| 21 | Hospital La Paz | Madrid | Spain | 28046 | |
| 22 | Hospital Virgen de Macarena | Seville | Spain | 41009 | |
| 23 | Clínica Sagrado Corazón | Seville | Spain | 41013 | |
| 24 | Hospital Virgen del Rocío | Seville | Spain | 41013 | |
| 25 | Hospital Nuestra Señora de Valme | Seville | Spain | 41014 | |
| 26 | Hospital La Fe | Valencia | Spain | 46009 | |
| 27 | Hospital Clínico de Valencia | Valencia | Spain | 46010 | |
| 28 | Hospital General de Valencia | Valencia | Spain | 46014 | |
| 29 | Hospital Doctor Peset | Valencia | Spain | 46017 |
Sponsors and Collaborators
- Fundacion SEIMC-GESIDA
- Astellas Pharma Inc
- Gilead Sciences
- Merck Sharp & Dohme LLC
- Pfizer
Investigators
- Study Director: Manuel Cuenca, MD, PhD, Instituto de Salud Carlos III
- Study Director: Belen Padilla, MD, Hospital Gregorio Marañon
- Study Director: Isabel Ruiz, MD, Hospital Vall d'Hebron
- Study Director: Jose Garnacho-Montero, MD, Hospital Virgen del Rocio
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GEMICOMED-GEIH 0109