Prospective Population Study on Candidemia in Spain NCT01236261

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01236261
Other study ID #	GEMICOMED-GEIH 0109
Secondary ID
Status	Completed
Phase	N/A
First received	November 5, 2010
Last updated	April 22, 2013
Start date	March 2013
Est. completion date	March 2013

Study information
Verified date	April 2013
Source	Fundacion SEIMC-GESIDA
Contact	n/a
Is FDA regulated	No
Health authority	Spain: Agencia Española de Medicamentos y Productos Sanitarios
Study type	Observational

Clinical 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). The study is to be performed in five big cities which represent different geographic areas: Barcelona, Bilbao, Madrid, Sevilla and Valencia.

Recruitment information / eligibility
Status	Completed
Enrollment	730
Est. completion date	March 2013
Est. primary completion date	March 2013
Accepts healthy volunteers	No
Gender	Both
Age group	N/A and older
Eligibility	Inclusion Criteria: - Fungal isolate obtained from blood sample Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Non intervention
Non interventional study

Locations
Country	Name	City	State
Spain	Hospital Fundación de Alcorcón	Alcorcón	Madrid
Spain	Hospital de Cruces	Baracaldo	Vizcaya
Spain	Hospital Clinic i Provincial	Barcelona
Spain	Hospital de Barcelona	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	Hospital de Basurto	Basurto	Vizcaya
Spain	Hospital San Juan de Dios del Aljarafe	Bormujos	Seville
Spain	Hospital Sant Joan de Dèu	Esplugues de Llobregat	Barcelona
Spain	Hospital de Galdakao-Usansolo	Galdakao	Vizcaya
Spain	Fundación Jiménez Díaz	Madrid
Spain	Hospital 12 de Octubre	Madrid
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital de la Princesa	Madrid
Spain	Hospital del Niño Jesús	Madrid
Spain	Hospital Gregorio Marañon	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramon y Cajal	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Clínica Sagrado Corazón	Seville
Spain	Hospital Nuestra Señora de Valme	Seville
Spain	Hospital Virgen de Macarena	Seville
Spain	Hospital Virgen del Rocío	Seville
Spain	Hospital Clínico de Valencia	Valencia
Spain	Hospital Doctor Peset	Valencia
Spain	Hospital General de Valencia	Valencia
Spain	Hospital La Fe	Valencia

Sponsors *(5)*
Lead Sponsor	Collaborator
Fundacion SEIMC-GESIDA	Astellas Pharma Inc, Gilead Sciences, Merck Sharp & Dohme Corp., Pfizer

Country where clinical trial is conducted

Spain,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	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)	1 year	No
Secondary	Definition of risk factors	Determine risk factors for: bad clinical evolution infection by a specific Candida species fluconazole resistant isolate fungemia persistency	1 year	No
Secondary	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	1 year	No
Secondary	Correlation between fungemia with a diminished susceptibility fungal strain and clinical evolution	Chi-square and Kaplan-Meier survival curves	1 year	No
Secondary	Correlation between reference and commercial microbiological methods	Comparison of results when a reference or a commercial fungal identification and antifungal susceptibility method is used.	1 year	No

See also
Status	Clinical Trial	Phase
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Completed	`NCT01359891` - Clinical Evaluation of Novel Biomarkers in Patients With Septicemia
Completed	`NCT00794703` - A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections	Phase 3
Completed	`NCT00001937` - Comparing the Effectiveness of Fluconazole and a New Medicine (FK463) in Preventing Fungal Infections in Bone Marrow Transplant Patients	Phase 3
Recruiting	`NCT01260974` - Caspofungin as Prophylaxis in High Risk Liver Transplantation Recipients	Phase 2
Recruiting	`NCT04368559` - Study of Rezafungin Compared to Standard Antimicrobial Regimen for Prevention of Invasive Fungal Diseases in Adults Undergoing Allogeneic Blood and Marrow Transplantation	Phase 3
Active, not recruiting	`NCT02743585` - Impact of Rapid Pathogen Identification From Blood Cultures (RABbIT)	N/A
Completed	`NCT03876990` - Clinical and Medico-economic Evaluation of a Rapid Test (ePlex-BCID®, GenMark) for the Diagnosis of Bacteremia and Fungemia.	N/A
Completed	`NCT02734862` - CD101 Compared to Caspofungin Followed by Oral Step Down in Subjects With Candidemia and/or Invasive Candidiasis-Bridging Extension	Phase 2
Completed	`NCT02719769` - Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture	N/A
Completed	`NCT01450358` - Evaluation in the Treatment of Nosocomial Sepsis Comparing Polymerase Chain Reaction With Conventional Blood Culture.	Phase 4
Completed	`NCT00841971` - Anidulafungin Versus Fluconazole for the Prevention of Fungal Infections in Liver Transplant Recipients	Phase 4
Completed	`NCT01898208` - Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures	N/A
Terminated	`NCT00806351` - An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Serious Fungal Infection Due To Candida In Patients With A Dysfunctional Immune System	Phase 3
Terminated	`NCT00805740` - An Evaluation Of The Effectiveness And Safety Of Anidulafungin Compared To Caspofungin For The Treatment Of Deep Tissue Infection Due To Candida	Phase 3
Unknown status	`NCT00460330` - Evaluate Three Methods for Diagnosis of Invasive Fungal Infection in Chinese Patients After HSCT	N/A
Completed	`NCT00001810` - An Open Label, Non-Comparative, Multicenter, Phase III Trial of the Efficacy, Safety and Toleration of Voriconazole in the Primary or Secondary Treatment of Invasive Fungal Infections	Phase 3

Prospective Population Study on Candidemia in Spain

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (5)

Country where clinical trial is conducted

Outcome