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Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors

Spanish Cohort of Bacteriemias 2016: Epidemiology, Clinical Management and Prognostic Factors at Diagnosis.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03148769
Acronym
PRO-BAC
Enrollment
5320
Registered
2017-05-11
Start date
2016-10-31
Completion date
2019-05-31
Last updated
2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacteremia

Keywords

Bloodstream infections, epidemiology

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.

Interventions

None listed

Sponsors

Hospital Universitario Virgen Macarena
CollaboratorOTHER
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Epidemiology and prognostic factors of bacteremia episodes.From day 0 to day 30* Global incidence and per type of acquisition. * Global etiology and per type of acquisition. * Frequency of multiresistant and emerging microorganism. * Source of bacteremia. * Clinical severity of presentation. * Clinical failure, mortality at day 7, mortality at day 30, recurrence, length of stay and re-admission at hospital.

Secondary

MeasureTime frameDescription
Clinical management of patients with bacteremia during the episode.From day 0 to day 30* Antibiotic therapy used during the episodes (empirical and targeted). * Non antibiotic therapy/support therapy used during the episode. * Frequency of focus search and adequate control.
Influence of clinical management in the prognosis.From day 0 to day 30\- Identifying prognostic factors related with mortality, clinical failure and recurrence.
Differences in the management between types of services, wards and hospitals.From day 0 to day 30Comparison between different services and hospital wards of variables regarding on the management of episodes.
Quality indicators in the management of bacteremia.From day 0 to day 30\- Identifying quality indicators in the management of episodes of bacteremia.
Interventions made by Bacteremia Team.From day 0 to day 30* Frequency and type of interventions made by Bacteremia Teams. * Impact of these interventions in the management and prognosis of episodes.
Developing and validating a predictive model for early and late mortality.From day 0 to day 30\- Developing and validating a predictive model for mortality based in prognostic factors related with mortality.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026