Clinical trial NCT03148769: Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors
Official title: Spanish Cohort of Bacteriemias 2016: Epidemiology, Clinical Management and Prognostic Factors at Diagnosis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Keywords: Bloodstream infections, epidemiology
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Virgen Macarena
First posted: 2017-05-11
Enrollment: 5320
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will be included all episodes of bacteremia diagnosed over a year in all participating hospitals in patients over 13 years old. It´s no possible to make a calculation of the sample size, this will depend on the type of hospital, the number of beds of the same and the number of blood cultures that are requested during the period of recruitment of the study.

Brief summary: Bacteremia

The Hypothesis of the study are the followings:

* To demonstrate relevant epidemiologic and clinical changes with potentially impact in the management and prognosis of the patients with bacteremia.
* Since the diagnosis and management is heterogeneous between centers, we could identify a scenario to improve.
* To identify quality indicators in the management of bacteremia.
* To demonstrate that some interventions made by Bacteremia Team pose relevant impact in the prognosis of bacteremia.


Eligibility criteria: Inclusion Criteria:

* Every episode of bacteremia in patients older than 13 years old, confirmed microbiologically and clinically significant (presence of clinical sepsis data at diagnosis) should be prospectively included on the basis of standard criteria.
* Episodes of transient bacteremia may be included.
* Drugs will be prescribed in the usual way, according to the conditions established in the authorization. The assignment of a patient to a particular therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice, and the decision to prescribe a particular drug will be clearly dissociated from the decision to include to the patient in the study.

Exclusion Criteria:

* Bacteremias without clinical relevance

Primary outcomes:
measure: Epidemiology and prognostic factors of bacteremia episodes.
timeFrame: From day 0 to day 30
Secondary outcomes:
measure: Clinical management of patients with bacteremia during the episode.
timeFrame: From day 0 to day 30
measure: Differences in the management between types of services, wards and hospitals.
timeFrame: From day 0 to day 30
measure: Influence of clinical management in the prognosis.
timeFrame: From day 0 to day 30
measure: Developing and validating a predictive model for early and late mortality.
timeFrame: From day 0 to day 30
measure: Quality indicators in the management of bacteremia.
timeFrame: From day 0 to day 30
measure: Interventions made by Bacteremia Team.
timeFrame: From day 0 to day 30
Other outcomes:
Locations:
city: El Ejido
country: Spain
facility: Public Health Agency Business Hospital de Poniente.
state: Almería
city: Granollers
country: Spain
facility: General Hospital of Granollers
state: Barcelona
city: Terrassa
country: Spain
facility: University Hospital Mútua de Terrasa
state: Barcelona
city: Algeciras
country: Spain
facility: Hospital Punta Europa
state: Cádiz
city: Jerez de la Frontera
country: Spain
facility: Jerez de la Frontera Hospital
state: Cádiz
city: Ubeda
country: Spain
facility: Hospital San Juan de la Cruz
state: Jaen
city: Ponferrada
country: Spain
facility: Hospital El Bierzo
state: León
city: Márbella
country: Spain
facility: Costa del Sol Hospital
state: Málaga
city: Vigo
country: Spain
facility: University Hospital of Vigo
state: Pontevedra
city: Alicante
country: Spain
facility: University General Hospital of Alicante
city: Almeria
country: Spain
facility: Torrecárdenas Hospital
city: Barcelona
country: Spain
facility: L´ Esperit Sant ( Santa Coloma Granemet) Hospital
city: Burgos
country: Spain
facility: University Hospital of Burgos
city: Cordoba
country: Spain
facility: University Hospital Reina Sofía
city: Cádiz
country: Spain
facility: University Hospital Puerta del Mar
city: Cádiz
country: Spain
facility: La Linea de la Concepción Hospital
city: Cádiz
country: Spain
facility: Puerto Real Hospital
city: Granada
country: Spain
facility: University Hospital San Cecilio
city: Granada
country: Spain
facility: University Hospital Virgen de las Nieves
city: Jaen
country: Spain
facility: Ciudad de Jaén Hospital
city: León
country: Spain
facility: University Hospital of León
city: Lleida
country: Spain
facility: University Hospital Arnau de Vilanova
city: Málaga
country: Spain
facility: University Hospital Carlos Haya ( Málaga)
city: Oviedo
country: Spain
facility: Central University Hospital of Asturias
city: Pamplona
country: Spain
facility: University Clinic of Navarra
city: Santander
country: Spain
facility: University Hospital Marqués de Valdecilla
city: Sevilla
country: Spain
facility: University Hospital Virgen Macarena
city: Sevilla
country: Spain
facility: University Virgen de Valme Hospital
city: Vizcaya
country: Spain
facility: Universitary Hospital Cruces
Study officials:
affiliation: Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena
name: Jesús Rodríguez-Baño, MD PhD
role: STUDY_DIRECTOR
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