Spanish Bacteriemia Cohort 2016: Epidemiology, Clinical Management and Prognosis Factors (PRO-BAC)

May 20, 2019 updated by: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

5320

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03012
        • University General Hospital of Alicante
      • Almeria, Spain, 04009
        • Torrecárdenas Hospital
      • Barcelona, Spain, 08923
        • L´ Esperit Sant ( Santa Coloma Granemet) Hospital
      • Burgos, Spain, 09006
        • University Hospital of Burgos
      • Cordoba, Spain, 14004
        • University Hospital Reina Sofía
      • Cádiz, Spain, 11009
        • University Hospital Puerta del Mar
      • Cádiz, Spain, 11300
        • La Linea de la Concepción Hospital
      • Cádiz, Spain, 11510
        • Puerto Real Hospital
      • Granada, Spain, 18012
        • University Hospital San Cecilio
      • Granada, Spain, 18014
        • University Hospital Virgen de las Nieves
      • Jaen, Spain, 23007
        • Ciudad de Jaen Hospital
      • León, Spain, 24001
        • University Hospital of León
      • Lleida, Spain, 25198
        • University Hospital Arnau de Vilanova
      • Málaga, Spain, 29010
        • University Hospital Carlos Haya ( Málaga)
      • Oviedo, Spain, 33011
        • Central University Hospital of Asturias
      • Pamplona, Spain, 31008
        • University Clinic of Navarra
      • Santander, Spain, 30008
        • University Hospital Marqués de Valdecilla
      • Sevilla, Spain, 41009
        • University Hospital Virgen Macarena
      • Sevilla, Spain, 41014
        • University Virgen de Valme Hospital
      • Vizcaya, Spain, 48903
        • Universitary Hospital Cruces
    • Almería
      • El Ejido, Almería, Spain, 04700
        • Public Health Agency Business Hospital de Poniente.
    • Barcelona
      • Granollers, Barcelona, Spain, 08402
        • General Hospital of Granollers
      • Terrassa, Barcelona, Spain, 08221
        • University Hospital Mutua de Terrasa
    • Cádiz
      • Algeciras, Cádiz, Spain, 11207
        • Hospital Punta Europa
      • Jerez de la Frontera, Cádiz, Spain, 11138
        • Jerez de la Frontera Hospital
    • Jaen
      • Ubeda, Jaen, Spain, 23400
        • Hospital San Juan de la Cruz
    • León
      • Ponferrada, León, Spain, 24404
        • Hospital El Bierzo
    • Málaga
      • Márbella, Málaga, Spain, 29603
        • Costa del Sol Hospital
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
        • University Hospital of Vigo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiology and prognostic factors of bacteremia episodes.
Time Frame: 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.
From day 0 to day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical management of patients with bacteremia during the episode.
Time Frame: 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.
From day 0 to day 30
Differences in the management between types of services, wards and hospitals.
Time Frame: From day 0 to day 30
Comparison between different services and hospital wards of variables regarding on the management of episodes.
From day 0 to day 30
Influence of clinical management in the prognosis.
Time Frame: From day 0 to day 30
- Identifying prognostic factors related with mortality, clinical failure and recurrence.
From day 0 to day 30
Developing and validating a predictive model for early and late mortality.
Time Frame: From day 0 to day 30
- Developing and validating a predictive model for mortality based in prognostic factors related with mortality.
From day 0 to day 30
Quality indicators in the management of bacteremia.
Time Frame: From day 0 to day 30
- Identifying quality indicators in the management of episodes of bacteremia.
From day 0 to day 30
Interventions made by Bacteremia Team.
Time Frame: 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.
From day 0 to day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Collaborators

Hospital Universitario Virgen Macarena

Investigators

  • Study Director: Jesús Rodríguez-Baño, MD PhD, Unidad Clínica de Enfermedades Infecciosas, Microbiología. Hospital Universitario Virgen Macarena

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

May 8, 2017

First Posted (Actual)

May 11, 2017

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 20, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIS-AMO-2016-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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